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"sternotomy"
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The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial
by
Bouglé, Adrien
,
Lafourcade, Alexandre
,
Tran Dinh, Alexy
in
Academic Medical Centers - organization & administration
,
Academic Medical Centers - statistics & numerical data
,
Aged
2019
Purpose
Postoperative pain after cardiac surgery, exacerbated by cough and sternal mobilization, limits clearance of bronchopulmonary secretions and may predispose to postoperative pneumonia. In this study, we tested the ability of local anesthetic continuous wound infusion to prevent pneumonia after cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) owing to better analgesia and bronchopulmonary drainage.
Methods
In this randomized, double-blind, placebo-controlled trial conducted in five academic centers, patients undergoing cardiac surgery with sternotomy and CPB were enrolled from February 2012 until November 2014, and were followed over 30 days. Patients were assigned to a 48-h infusion (10 ml h
−1
) of
l
-bupivacaine (12.5 mg h
−1
) or placebo (saline) via a pre-sternal multiperforated catheter. Anesthesia and analgesia protocols were standardized. The primary end point was the incidence of pneumonia during the study period, i.e., until hospital discharge or 30 days. We hypothesized a 30% reduction in the incidence of pneumonia.
Results
Among 1493 randomized patients, 1439 completed the trial. Pneumonia occurred in 36/746 patients (4.9%) in the
l
-bupivacaine group and in 42/739 patients (5.7%) in the placebo group (absolute risk difference taking into account center and baseline risk of postoperative pneumonia, − 1.3% [95% CI − 3.4; 0.8]
P
= 0.22). In the predefined subgroup of patients at high risk,
l
-bupivacaine decreased the incidence of pneumonia (absolute risk difference, − 5.6% [95% CI − 10.0; − 1.1],
P
= 0.01).
Conclusions
After cardiac surgery with sternotomy, continuous wound infusion of
l
-bupivacaine failed to decrease the incidence of pneumonia. These findings do not support the use of local anesthetic continuous wound infusion in this indication. Further study should investigate its effect in high-risk patients.
Trial registration
EudraCT Number: 2011-003292-10; Clinicaltrials.gov Identifier: NCT01648777.
Journal Article
Ultrasound-guided mid-point transverse process to pleura block versus thoracic paravertebral block in pediatric open-heart surgery: A randomized controlled non-inferiority study
by
Abourezk, Ahmed Refaat
,
Badran, Aboelnour
,
Abdelbaser, Ibrahim
in
Analgesics
,
Anesthesia
,
Anesthetics, Local - administration & dosage
2024
The mid-point transverse process to pleura block (MTPB) is a new variant of thoracic paravertebral block (TPVB). This study aimed to compare TPVB and MTPB with respect to intraoperative attenuation of the hemodynamic stress response to surgery and postoperative analgesia in pediatric open heart surgery with midline sternotomy.
A single-center, randomized, controlled, double-blind, non-inferiority study.
Tertiary care children's university hospital.
We recruited 83 children aged 2–12 years of both sexes with American Society of Anesthesiologists (ASA) physical status class II who were scheduled for elective open cardiac surgeries with midline sternotomy for the repair of simple noncyanotic congenital heart defects.
Eligible participants were randomized into either the TPVB or MTPB groups at a ratio of 1:1. In the TPVB group, patients were bilaterally injected with 0.4 ml/kg of 0.25% bupivacaine in the paravertebral space at T4 and T5. In the MTPB group, patients were bilaterally injected with 0.4 ml/kg of 0.25% bupivacaine mid-transverse process and pleura just posterior to superior costotransverse ligament at the level of T4 and T5.
The primary outcome was the hemodynamic responses to sternotomy incision, including heart rate (HR) and invasive mean arterial pressure (MAP), recorded before and after the induction of anesthesia, after skin incision, after sternotomy, 15 min after cardiopulmonary bypass (CPB), and after the closure of the sternum. The secondary outcomes were time needed to perform the bilateral block, intraoperative fentanyl consumption, postoperative fentanyl consumption, modified objective pain score (MOPS) measured at 1, 2, 6, 12, 18, and 24 h after extubation, extubation time, intensive care unit (ICU) discharge time, and the incidence of non-surgical complications (postoperative pruritus, postoperative vomiting, pneumothorax, hematoma or local anesthetic toxicity).
There were no significant differences in HR and MAP in the TPVB group compared with the MTPB group at the following time points: baseline, after induction, after skin incision, after sternotomy, 15 min after CPB, and after sternal closure. Intergroup comparisons of HR and MAP did not reveal significant differences between the groups. The median (IQR) time needed to perform bilateral MTPB (7[6–8] min) was significantly (p < 0.001) shorter than that of TPVB (12[10−13] min). Intraoperative fentanyl consumption and fentanyl consumption in the first postoperative 24 h after extubation were similar in the TPVB and MTPB groups (4[2–4] vs 4[2–4] and 4.66 ± 0.649 vs 4.88 ± 1.082 μg/kg), respectively. Extubation time and ICU discharge time were comparable in the TPVB and MTPB groups (2[1–3] vs 2[1–3] h and 21.2 ± 2.5 vs 20.8 ± 2.6 h), respectively. Measurements of MOPS pain scores at 1, 2, 6, 12, 18, and 24 h after extubation were similar in both groups. The incidence of nonsurgical complications was similar in both groups.
MTPB is non-inferior to TPVB in attenuating the intraoperative hemodynamic stress response to noxious surgical stimuli and in reducing perioperative opioid consumption, extubation time, and ICU discharge time. Moreover, MTPB is technically easier than TPVB and requires less time to perform.
Clinical trial registration number
The clinical trial registration was prospectively performed at the Pan African Clinical Trials Registry (PACTR202204901612169, approval date 01/04/2022, URL https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=22602).
•Mid-point transverse process to pleura block (MTPB) is a new variant of thoracic paravertebral block (TPVB).•The effectiveness of TPVB in blunting hemodynamic stress response and postoperative analgesia is well-established.•MTPB is non-inferior to TPVB in attenuation surgical hemodynamic stress response and providing perioperative analgesia.
Journal Article
A Randomized, Placebo-Controlled, Double-Blind, Prospective Clinical Trial of Botulinum Toxin Type A in Prevention of Hypertrophic Scar Development in Median Sternotomy Wound
by
Yang, Jiaomei
,
Ju-Lei, Zhang
,
Zhang, Wei
in
Botulinum toxin
,
Clinical trials
,
Double-blind studies
2018
BackgroundLinear hypertrophic scar is a common surgical problem that can be difficult to manage, especially for the median sternotomy scar. Botulinum toxin type A (BTA) is widely used in cosmetic surgery and has been shown to improve scar quality recently. The aim of this study was to evaluate the efficacy of BTA injected in the early postoperative of median sternotomy on preventing scar formation.MethodsIn this prospective randomized controlled trial, 19 consecutive patients who underwent median sternotomy were enrolled. The median sternotomy wound in each patient was divided into the upper half and the lower half. Both halves of the wound were randomized to receive the treatment with either BTA or normal saline. At 6-month follow-up, scars were assessed using the Vancouver Scar Scale, scar widths were measured, and patients were asked to evaluate their overall satisfaction.ResultsSeventeen patients with median sternotomy wounds completed the entire study. At 6-month follow-up, the mean Vancouver Scar Scale score for the BTA-treated group was 3.44 ± 1.68 and for the normal saline control group was 6.29 ± 2.39, and there was a statistically significant difference between the two groups (P < 0.05). There were also significant improvements in scar width and patient satisfaction for the BTA-treated halves of the wounds (P < 0.05).ConclusionsThe study demonstrates that early postoperative BTA injection can decrease scar formation and reduce scar width in median sternotomy wounds, and the overall appearance is more satisfactory.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Journal Article
Bleeding in minimally invasive versus conventional aortic valve replacement
by
Bratt, Sorosh
,
Franco-Cereceda, Anders
,
Lilford, Robert D.
in
Aged
,
Aged, 80 and over
,
Anticoagulants
2024
Background
Observational studies have shown reduced perioperative bleeding in patients undergoing minimally invasive, compared with full sternotomy, aortic valve replacement. Data from randomized trials are conflicting.
Methods
This was a Swedish single center study where adult patients with aortic stenosis, 100 patients were randomly assigned in a 1:1 ratio to undergo either minimally invasive (ministernotomy) or full sternotomy aortic valve replacement. The primary outcome was severe or massive bleeding defined by the Universal Definition of Perioperative Bleeding in adult cardiac surgery (UDPB). Secondary outcomes included blood product transfusions, chest tube output, re-exploration for bleeding, and several other clinically relevant events.
Results
Out of 100 patients, three patients randomized to ministernotomy were intraoperatively converted to full sternotomy (none was bleeding-related). Three patients (6%) in the full sternotomy group and 3 patients (6%) in the ministernotomy group suffered severe or massive postoperative bleeding according to the UDPB definition (
p
= 1.00). Mean chest tube output during the first 12 postoperative hours was 350 (standard deviation (SD) 220) ml in the full sternotomy group and 270 (SD 190) ml in the ministernotomy group (
p
= 0.08). 28% of patients in the full sternotomy group and 36% of patients in the ministernotomy group received at least one packed red blood cells transfusion (
p
= 0.39). Two patients in each group (4%) underwent re-exploration for bleeding.
Conclusions
Minimally invasive aortic valve replacement did not result in less bleeding-related outcomes compared to full sternotomy.
Clinical Trial Registration
http://www.clinicaltrials.gov
. Unique identifier: NCT02272621.
Journal Article
Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial
by
Owens, W. Andrew
,
Akowuah, Enoch
,
Goodwin, Andrew T.
in
Aortic Valve - surgery
,
Biomarkers - blood
,
Biomedicine
2017
Background
Aortic valve replacement is one of the most common cardiac surgical procedures performed worldwide. Conventional aortic valve replacement surgery is performed via a median sternotomy; the sternum is divided completely from the sternal notch to the xiphisternum. Minimally invasive aortic valve replacement, using a new technique called manubrium-limited ministernotomy, divides only the manubrium from the sternal notch to 1 cm below the manubrio-sternal junction.
More than one third of patients undergoing conventional sternotomy develop clinically significant bleeding requiring post-operative red blood cell transfusion. Case series data suggest a potentially clinically significant difference in red blood cell transfusion requirements between the two techniques. Given the implications for National Health Service resources and patient outcomes, a definitive trial is needed.
Methods/design
This is a single-centre, single-blind, randomised controlled trial comparing aortic valve replacement surgery using manubrium-limited ministernotomy (intervention) and conventional median sternotomy (usual care). Two hundred and seventy patients will be randomised in a 1:1 ratio between the intervention and control arms, stratified by baseline logistic EuroSCORE and haemoglobin value. Patients will be followed for 12 weeks from discharge following their index operation. The primary outcome is the proportion of patients who receive a red blood cell transfusion post-operatively within 7 days of surgery. Secondary outcomes include red blood cell and blood product transfusions, blood loss, re-operation rates, sternal wound pain, quality of life, markers of inflammatory response, hospital discharge, health care utilisation, cost and cost effectiveness and adverse events.
Discussion
This is the first trial to examine aortic valve replacement via manubrium-limited ministernotomy versus conventional sternotomy when comparing red blood cell transfusion rates following surgery. Surgical trials present significant challenges; strengths of this trial include a rigorous research design, standardised surgery performed by experienced consultant cardiothoracic surgeons, an agreed anaesthetic regimen, patient blinding and consultant-led patient recruitment. The MAVRIC trial will demonstrate that complex surgical trials can be delivered to exemplary standards and provide the community with the knowledge required to inform future care for patients requiring aortic valve replacement surgery.
Trial registration
International Standard Randomised Controlled Trial Number (ISRCTN)
ISRCTN29567910
. Registered on 3 February 2014.
Journal Article
Rectus sheath block added to parasternal block may improve postoperative pain control and respiratory performance after cardiac surgery: a superiority single-blinded randomized controlled clinical trial
by
Sarubbi, Domenico
,
Stifano, Mariapia
,
Di Pumpo, Annalaura
in
Aged
,
Analgesics
,
Analgesics, Opioid
2025
BackgroundThe population undergoing cardiac surgery confronts challenges from uncontrolled post-sternotomy pain, with possible adverse effects on outcome. While the parasternal block can improve analgesia, its coverage may be insufficient to cover epigastric area. In this non-blinded randomized controlled study, we evaluated the analgesic and respiratory effect of adding a rectus sheath block to a parasternal block.Methods58 patients undergoing cardiac surgery via median sternotomy were randomly assigned to receive parasternal block with rectus sheath block (experimental) or parasternal block with epigastric exit sites of chest drains receiving surgical infiltration of local anesthetic (control). The primary outcome of this study was pain at rest at extubation. We also assessed pain scores at rest and during respiratory exercises, opiate consumption and respiratory performance during the first 24 hours after extubation.ResultsThe median (IQR) maximum pain scores (on a 0–10 Numeric Rate Scale (NRS)) at extubation were 4 (4, 4) in the rectus sheath group and 5 (4, 5) in the control group (difference 1, p value=0.03). Rectus sheath block reduced opioid utilization by 2 mg over 24 hours (IC 95% 0.0 to 2.0; p<0.01), reduced NRS scores at other time points, and improved respiratory performance at 6, 12, and 24 hours after extubation.ConclusionThe addition of a rectus sheath block with a parasternal block improves analgesia for cardiac surgery requiring chest drains emerging in the epigastric area.Trial registration number NCT05764616.
Journal Article
A prospective randomized study that compares three different dressings for the prevention of surgical site infections following major heart surgery
by
Valencia, Dominique Encarnación
,
Valerio, Maricela
,
Muñoz, Patricia
in
631/326/2521
,
692/700/459/1748
,
Absorbents
2025
Surgical site infection (SSI) is among the most common complication of major heart surgery patients with incidences ranging from 0.5 to 16.5%. Our aim was to compare the incidence, etiology and prognosis of surgical wound infection in three groups of patients with three different type of wound dressing used in a large cohort of patients undergoing cardiac surgery requiring median sternotomy (MHS). This was a randomized, prospective clinical study conducted in 900 adults undergoing MHS at our center from October 10, 2019 to February 22, 2022. Before surgical closure, patients were randomized to 3 different wound dressing groups (300 patients per group): A) conventional gauze (Mepore®), B) Absorbent: polyurethane foam (Mepilex®), or C) Vacuum-negative-pressure therapy (NPWT) wound dressing (PICO®, Smith & Nephew S.A.). Overall, 900 patients were randomized as follows: 300 patients in each group received conventional, absorbent or vacuum wound dressing respectively. Rates of SSI in groups A, B and C were respectively 2.3%, 3% and 3% for superficial SSI (sSSI) (p = 0.848) and 2%, 2% and 0.7% for postsurgical mediastinitis (PSM) (p = 0.313). Mortality in the whole group was 4.4% there being no significant differences between the three groups (4.7%, 5.7% and 3% respectively; p = 0.277). The NPWT system was better at preventing PSM than the other dressings only in the subgroup of patients undergoing coronary artery bypass graft surgery (CABG) with mammary artery grafts. We have not been able to demonstrate significant differences in the incidence of SSI in the whole series with any of the different dressings. The newer, more expensive, NPWT dressing were more effective only at preventing Post-Surgical Mediastinitis in patients undergoing CABG with internal mammary artery grafts. ClinicalTrials.gov identifier (NCT number): NCT03905213
Journal Article
Efficacy of bilateral catheter superficial parasternal intercostal plane blocks using programmed intermittent bolus for opioid-sparing postoperative analgesia in cardiac surgery with sternotomy: A randomized, double-blind, placebo-controlled trial
by
Liao, Yi
,
Zhan, Mingying
,
Wang, Xiaoe
in
Aged
,
Amides - administration & dosage
,
Analgesia, Patient-Controlled - methods
2024
This study investigated whether catheter superficial parasternal intercostal plane (SPIP) blocks, using a programmed intermittent bolus (PIB) with ropivacaine, could reduce opioid consumption while delivering enhanced analgesia for a period exceeding 48 h following cardiac surgery involving sternotomy.
A double-blind, prospective, randomized, placebo-controlled trial.
University-affiliated tertiary care hospital.
60 patients aged 18 or older, scheduled for cardiac surgery via sternotomy.
The patients were randomly assigned in a 1:1 ratio to either the ropivacaine or saline group. After surgery, patients received bilateral SPIP blocks for 48 h with 0.4% ropivacaine (20 mL per side) for induction, followed by bilateral SPIP catheters using PIB with 0.2% ropivacaine (8 mL/side, interspersed with a 2-h interval) or 0.9% normal saline following the same administration schedule. All patients were administered patient-controlled analgesia with hydromorphone.
The primary outcome was the cumulative morphine equivalent consumption during the initial 48 h after the surgery. Secondary outcomes included postoperative pain assessment using the Numeric Rating Scale (NRS) at rest and during coughing at designated intervals for three days post-extubation. Furthermore, recovery indicators and ropivacaine plasma levels were diligently documented.
Cumulative morphine consumption within 48 h in ropivacaine group decreased significantly compared to saline group (25.34 ± 31.1 mg vs 76.28 ± 77.2 mg, respectively; 95% CI, −81.9 to −20.0, P = 0.002). The ropivacaine group also reported lower NRS scores at all recorded time points (P < 0.05) and a lower incidence of nausea and vomiting than the saline group (3/29 vs 12/29, respectively; P = 0.007). Additionally, the ropivacaine group showed significant improvements in ambulation (P = 0.018), respiratory exercises (P = 0.006), and self-reported analgesia satisfaction compared to the saline group (P = 0.016).
Bilateral catheter SPIP blocks using PIB with ropivacaine reduced opioid consumption over 48 h, concurrently delivering superior postoperative analgesia in adult cardiac surgery with sternotomy.
•Postoperative pain after cardiac surgery is challenging.•Catheter superficial parasternal intercostal plane blocks using a programmed intermittent bolus regimen reduced the morphine equivalent requirement up to three days after surgery.•The technique also reduces the incidence of postoperative nausea and vomiting, facilitating postoperative recovery.
Journal Article
The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial
by
Dearani, Joseph A.
,
Gutierrez, Claudia N.
,
Stulak, John M.
in
Analgesics
,
Anxiety
,
Clinical trials
2020
To report the first randomized controlled trial to investigate if immersive virtual reality (VR) treatment can reduce patient perceptions of anxiety compared with a tablet-based control treatment in adults undergoing a first-time sternotomy.
Twenty first-time sternotomy patients were prospectively randomized (blinded to investigator) to a control or VR intervention. The VR intervention was a game module “Bear Blast” (AppliedVR) displayed using a Samsung Gear Oculus VR headset. The control intervention was a tablet-based game with comparable audio, visual, and tactile components. The State-Trait Anxiety Inventory was administered before and after the assigned intervention. Self-reported anxiety measures between the control and VR groups were evaluated using an unpaired t test. Changes in self-reported anxiety measures pre- and post-intervention were evaluated with a paired t test for both the control and VR groups. The study took place from May 1, 2017, through January 1, 2019 (Institutional Review Board 16-009784).
Both control and VR groups were 90.0% male, with a mean ± SD age of 63.4 ± 9.11 and 69.5 ± 6.9 years, respectively. VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05). They also experienced significant reductions in feeling strained, upset, and tense when compared with their own self-reported anxiety measure pre- and post-intervention (P<0.05). Critically, control patients had no change in these categories.
Immersive VR is an effective, nonpharmacologic approach to reducing preoperative anxiety in adults undergoing cardiac surgery and shows the validity and utility of this technology in adult patients.
Journal Article
Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial
by
Vistarini, Nicolas
,
Gibert, Hadrien
,
Perot, Brieuc P
in
anesthesia
,
Cardiac arrhythmia
,
Catheters
2021
ObjectiveThis study aims to assess the effect of a preoperative parasternal plane block (PSB) on opioid consumption required to maintain hemodynamic stability during sternotomy for coronary artery bypass graft surgery.MethodsThis double-blind, randomized, placebo-controlled trial prospectively enrolled 35 patients scheduled for coronary artery bypass graft surgery under general anesthesia with propofol and remifentanil. Patients were randomized to receive preoperative PSB using either ropivacaine (PSB group) or saline solution (placebo group) (1:1 ratio). The primary endpoint was the maximal effect-site concentration of remifentanil required to maintain heart rate and blood pressure within the recommended ranges during sternotomy.ResultsMedian maximum concentration of remifentanil necessary to maintain adequate hemodynamic status during sternotomy was significantly reduced in PSB group (4.2 (2.5–6.0) ng/mL) compared with placebo group (7.0 (5.2–8.0) ng/mL) (p=0.02). Mean maximum concentration of propofol used to control depth of anesthesia was also reduced (3.9±1.1 µg/mL vs 5.0±1.5 µg/mL, PSB vs placebo, respectively; p=0.02). This reduction in propofol consumption during sternotomy enabled a more adequate level of sedation to be maintained in patients (minimum patient state index was 11.7±8.7 in placebo group and 18.3±6.8 in PSB group; p=0.02). PSB reduced postoperative inflammatory response by limiting concentrations of proinflammatory cytokines IL-8, IL-18, IL-23, IL-33 and MCP-1 measured in the first 7-day after surgery (p<0.05).ConclusionsPreoperative PSB reduced the maximum concentrations of remifentanil and propofol required to maintain hemodynamic stability and depth of anesthesia during sternotomy.Trial registration number NCT03734159.Sébastien Bloc, M.D.1,2; Brieuc P. Pérot, Ph.D.3; Hadrien Gibert, M.D.1; Jean-Dominique Law Koune, M.D.1; Yannick Burg, M.D.1; Didier Leclerc, M.D.1; Anne-Sophie Vuitton, M.D.1; Christophe De La Jonquière, M.D.1; Marine Luka, L.S.3; Thierry Waldmann, M.D.4; Nicolas Vistarini, M.D.4; Stéphane Aubert, M.D.4; Mickaël M. Ménager, Ph.D.3; Messaouda Merzoug, Ph.D.2; Cécile Naudin, Ph.D.2; Pierre Squara, M.D.2,5
Journal Article