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result(s) for
"Punctures - adverse effects"
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Comparison of comfort and complications of Implantable Venous Access Port (IVAP) with ultrasound guided Internal Jugular Vein (IJV) and Axillary Vein/Subclavian Vein (AxV/SCV) puncture in breast cancer patients: a randomized controlled study
2022
Background
Axillary vein/subclavian vein (AxV/SCV) and Internal jugular vein (IJV) are commonly used for implantable venous access port (IVAP) implantation in breast cancer patients for chemotherapy. Previous research focused on comparison of complications while patient comfort was ignored. This study aims to compare patient comfort, surgery duration and complications of IVAP implantation between IJV and AxV/SCV approaches.
Methods
Two hundred forty-eight breast cancer patients were enrolled in this randomized controlled study from August 2020 to June 2021. Patients scheduled to undergo IVAP implantation were randomly and equally assigned to receive central venous catheters with either AxV /SCV or IJV approaches. All patients received comfort assessment using a comfort scale table at day 1, day 2 and day 7 after implantation. Patient comfort, procedure time of operation as well as early complications were compared.
Results
Patient comfort was significantly better in the AxV/SCV group than that of IJV group in day 1 (
P
< 0.001), day 2 (
P
< 0.001) and day 7(
P
= 0.023). Procedure duration in AxV/SCV group was slightly but significantly shorter than IJV group (27.14 ± 3.29 mins vs 28.92 ± 2.54 mins,
P
< 0.001). More early complications occurred in AxV/SCV group than IJV group (11/124 vs 2/124,
P
= 0.019). No difference of complications of artery puncture, pneumothorax or subcutaneous hematoma between these two groups but significantly more catheter misplacement in AxV/SCV group than IJV group (6/124 vs 0/124,
P
= 0.029). Absolutely total risk of complications was rather low in both groups (8.87% in AxV/SCV group and 1.61% in IJV group).
Conclusions
Our study indicates that patients with AxV/SCV puncture have higher comfort levels than IJV puncture. AxV/SCV puncture has shorter procedure duration but higher risk of early complications, especially catheter misplacement. Both these two approaches have rather low risk of complications. Consequently, our study provides an alternative choice for breast cancer patients to reach better comfort.
Journal Article
Vibration-based mitigation of noxious-evoked responses to skin puncture in neonates and infants: a randomised controlled trial
by
McLoughlin, Maeve
,
Srinivas, Rachelle
,
Kjeldsen, Caitlin P.
in
Data collection
,
Electroencephalography
,
Electroencephalography - methods
2024
ObjectiveTo assess the effect of a non-noxious vibratory stimulus on noxious-evoked cortical responses to skin puncture and to determine whether the presence of certain behavioural components may be used to predict such cortical responses.DesignRandomised controlled trial.SettingLevel IV neonatal intensive care unit at a stand-alone children’s hospital.Patients134 hospitalised infants between 36 and 52 weeks’ postmenstrual age and ordered to receive a clinically required laboratory draw.InterventionsInfants randomised to receive the intervention, a vibratory stimulus at the site of skin puncture beginning 10 s prior to a heel stick, or the control, no vibration.Main outcome measuresElectroencephalography and video recording time-locked to the deployment of the lancet for the skin puncture. Noxious-evoked cortical responses were measured by the area under the curve in the somatosensory region contralateral to the skin puncture. Behavioural responses were coded through video analysis.ResultsNoxious-evoked cortical responses were significantly reduced in participants receiving the vibratory stimulus compared with the control (frontal, p<0.0001; central, p=0.0088; central-parietal, p=0.0111). There were no significant differences in behavioural responses between groups (all p>0.05).ConclusionsA non-noxious vibratory stimulus presented prior to and continuing simultaneously with skin puncture significantly mitigates nociception in hospitalised infants. The presence or absence of facial expression components is inadequate to reliably predict pain signalling in the brain.Trial registration number NCT04050384.
Journal Article
Changing the needle for lumbar punctures: results from a prospective study
by
Vilholm, Ole Jakob
,
Ørding, Helle
,
Engedal, Thorbjørn S
in
Adult
,
Aged
,
Anesthesia, Spinal - statistics & numerical data
2015
Post-dural puncture headache (PDPH) is a common complication of diagnostic lumbar punctures. Both a non-cutting needle design and the use of smaller size needles have been shown to greatly reduce the risk of PDPH. Nevertheless, larger cutting needles are still widely used. This study describes the process of changing the needle in an outpatient clinic of a Danish neurology department.
Prospective interventional trial. Phase 1: 22G cutting needle. Phase 2: 25G non-cutting needle. Practical usability of each needle was recorded during the procedure, while the rate of PDPH and the occurrence of socioeconomic complications were acquired from a standardized questionnaire.
651 patients scheduled for diagnostic lumbar punctures were screened for participation and 501 patients were included. The response rate was 80% in both phases. In phase 2, significant reductions were observed in occurrence of PDPH (21 vs. 50, p=0.001), number of days spent away from work (55 vs. 175, p<0.001), hospitalizations (2 vs. 17, p<0.001), and number of bloodpatch treatments (2 vs. 10, p=0.019). Furthermore, during the procedure, both the need for multiple attempts (30% vs. 44%, p=0.001), and the failure-rate of the first operator (17% vs. 29%, p=0.005) were reduced.
Our study showed that smaller, non-cutting needles reduce the incidence of PDPH and are easily implemented in an outpatient clinic. Changing the needle resulted in fewer socioeconomic complications and fewer overall costs, while also reducing procedural difficulty.
Journal Article
Clinical Effect of Modified Ultrasound-Guided Subclavian Vein Puncture
by
Ma, Yu-Jie
,
Liu, Tao
,
Zhang, Yun-Shui
in
Blood vessels
,
Catheterization
,
Catheterization, Central Venous - adverse effects
2023
Objective. This study compared the effect of ultrasound-guided subclavian vein puncture with traditional blind puncture and the double-screen control method by evaluating the one-time puncture success and total success rates, the completion time for puncture and catheterization, and short-term complications. Methods. From January 2020 to January 2021, 72 patients with right subclavian venipuncture catheterization were collected, 12 of whom were excluded (including 3 cases of pneumothorax, 2 cases of hemothorax, 1 case of difficult positioning of thoracic deformity, 1 case of severe drug eruption, 3 cases of clavicle fracture, and 1 case of severe coagulation dysfunction). The remaining 60 cases were randomly divided into the traditional group (n = 30) and the improved group (n = 30). We record two sets of ultrasound localization time, puncture time, one-time puncture power, total puncture success rate, and short-term (24-hour) complications. Results. Compared with the traditional group, the ultrasound positioning time and puncture time in the improved group were significantly reduced and the puncture success rate was higher. There were no complications, such as incorrect arterial puncture and the occurrence of pneumothorax, in either group. Conclusion. The improved ultrasound-guided subclavian vein catheterization technique can greatly reduce the catheterization time and improve the success rate of puncture and catheterization. It can also reduce the occurrence of complications and damage to adjacent tissues. The operation is simple, fast, and easy to master, and it has a high popularization clinical value.
Journal Article
Are corticosteroid injections needed after needling and lavage of calcific tendinitis? Randomised, double-blind, non-inferiority trial
by
Darrieutort-Laffite, Christelle
,
Varin, Stephane
,
Coiffier, Guillaume
in
Acute Pain - etiology
,
Acute Pain - prevention & control
,
Adult
2019
ObjectiveSteroid injections are common after an ultrasound-guided puncture and lavage (UGPL) of calcific tendonitis of the rotator cuff. However, steroids may prevent calcification resorption and negatively affect tendon healing. Our study was designed to determine whether saline solution was non-inferior to steroids in the prevention of acute pain reactions in the week following UGPL.MethodsThis was a randomised, double-blinded, controlled non-inferiority trial with 12-month follow-up. We included 132 patients (66 in each group) with symptomatic calcification measuring more than 5 mm. Patients received 1 mL of saline or steroid (methylprednisolone 40 mg) in the subacromial bursa at the end of UGPL. Primary outcome was the maximal pain during the week following the procedure with a prespecified non-inferiority margin of 10 mm (0–100 visual analogue scale). Secondary outcomes included pain at rest and during activity, function (disabilities of the arm, shoulder and hand score) and radiological evolution of the calcification over the 12-month follow-up.ResultsThe estimated mean difference in the first week’s maximal pain between these two groups was 11.76 (95% CI 3.78 to 19.75). Steroids significantly improved VAS pain at rest and during activities, as well as function at 7 days and 6 weeks. They did not change the rate of calcification resorption, which occurred in 83% and 74% of patients at 12 months in the saline and steroid groups.ConclusionNon-inferiority of saline when compared with steroids could not be established. However, steroid injection improved pain in the 6 weeks following the procedure, and function in the 3 months after, with no significant effect on calcification resorption.Trial registration numberNTC02403856.
Journal Article
The prospective self-controlled study of unilateral transverse process-pedicle and bilateral puncture techniques in percutaneous kyphoplasty
Summary
Many previous studies have reported excellent clinical results with percutaneous kyphoplasty (PKP). In contrast, numerous complications and problems have also been reported, such as puncture difficulty, cement leakage, and adjacent vertebral fracture.
Introduction
This study is to evaluate the application and clinical outcomes of unilateral transverse process-pedicle and bilateral PKP in the treatment of osteoporotic vertebral compression fractures (OVCF).
Methods
A total of 56 cases with two levels thoracolumbar OVCF were randomly assigned for treatment with unilateral transverse process-pedicle and bilateral PKP. The patients were followed up postoperatively and were assessed mainly with regard to clinical and radiologic outcomes. Clinical outcomes were evaluated with mainly the use of a visual analogue scale (VAS) for pain. Radiologic outcomes were assessed mainly on the basis of radiation dose and bone cement distribution.
Results
The operation was completed successfully in 56 cases. In the unilateral level, the operation time, the volume of the injected cement, and radiation dose were significantly less than bilateral level. All patients had significantly improvement on VAS score after the procedures, compared with their preoperative period. In the bilateral level, 7 patients had obvious pain in the puncture sites at 1 month postoperatively caused by facet joint violation. With local block treatment, the pain disappeared in all patients at the last follow-up.
Conclusion
Both bilateral and unilateral PKP are relatively safe and effective treatments for patients with painful OVCF. But unilateral PKP received less radiation dose and operation time, offered a higher degree of deformity correction, and resulted in less complication than bilateral.
Journal Article
Effect of lidocaine spray on reliving non-coring needle puncture-related pain in patients with totally implantable venous access port: a randomized controlled trial
by
Zhu, Ying
,
Chang, Jian
,
Zhang, Yejun
in
Anesthetics, Local - therapeutic use
,
Catheterization, Central Venous - adverse effects
,
China
2023
Patients with the placement of a totally implantable venous access port (TIVAP) commonly suffer from pain caused by inserting a non-coring needle. At present, lidocaine cream and cold spray are extensively used for pain management, but they are complex to manage in busy medical environments and developing countries. The lidocaine spray combines the analgesic effect of lidocaine cream and the rapid onset of cold spray, which can effectively alleviate the pain related to non-coring needle puncture in patients with TIVAP. This randomized-controlled trial aimed to explore the effectiveness, acceptability, and safety of lidocaine spray in relieving the pain of non-coring needle puncture in patients with TIVAP.
A total of 84 patients who were hospitalized in the oncology department of a Grade III Level-A hospital in Shanghai from January 2023 to March 2023 and were implanted with TIVAP and required non-coring needle puncture were selected as the study subjects. The recruited patients were randomly assigned to the intervention group and the control group (n=42). Before routine maintenance, the intervention group received lidocaine spray 5 min before disinfection, while the control group received water spray 5 min before disinfection. The main clinical outcome was pain, and the degree of puncture pain in both groups was evaluated using the visual analogue scale.
There were no significant differences between the two groups in age, gender, educational level, body mass index, port implantation time, and disease diagnosis (P>0.05). The pain score in the intervention and control groups was 15.12±6.61mm and 36.50±18.79mm, respectively (P<0.001). There were 2 (4.8%) patients with moderate pain in the intervention group and 18 (42.9%) patients with moderate pain in the control group (P<0.001). In the control group, 3 (7.1%) patients reported severe pain. The median comfortability score for the two groups of patients was 10, but there was a difference between the two groups (P<0.05) because the intervention group tilted to the right. The successful puncture rate of the first time puncture had no difference between the two groups, both being 100%. Moreover, 33 patients (78.6%) in the intervention group and 12 patients (28.6%) in the control group reported that they would choose the same spray for intervention in the future (P<0.001). During the 1 week of follow-up, 1 patient in the intervention group developed skin itching (P>0.05).
The local use of lidocaine spray in patients with TIVAP is effective, acceptable, and safe to alleviate the pain caused by non-coring needle puncture.
Chinese Clinical Trial Registry (registration number: ChiCTR2300072976).
Journal Article
Ultrasound guidance in difficult radial artery puncture for blood gas analysis: A prospective, randomized controlled trial
by
Muller, Laurent
,
Pommet, Stéphane
,
Genre Grandpierre, Romain
in
Aged
,
Anesthesiology
,
Arteries
2019
Ultrasound (US) guidance has yet to prove its applicability in radial arterial blood gas analysis (ABGA) punctures. The main objective of our study was to compare the number of first-attempt successes (NFAS) for radial arterial puncture in difficult patients with or without US guidance. The Secondary aims were to compare the number of punctures (NOP), puncture time, and patient pain.
In this single-center, randomized controlled trial, patients who required a radial ABGA and in whom the arterial puncture was assessed as difficult (because of non-palpable radial arteries or two previous puncture failures by a nurse) were assigned to the US group or no-US (NUS) group (procedure performed by a trained physician).
Thirty-six patients were included in the US group and 37 in the NUS groups. The NFAS was 7 (19%) in the NUS group and 19 (53%) in the US group. The relative risk of success in the US group was 2.79 (95% CI,1.34 to 5.82), p = 0.01. In the NUS and US groups, respectively, the median NOP was 3 [2; 6] vs. 1 [1; 2], estimated difference -2.0 (95%CI, -3.4 to -0.6), p < 0.01; the respective puncture time was 3.1 [1.6; 5.4] vs. 1.4 [0.6; 3.1] min, estimated difference -1.45 (95%CI, -2.57 to -0.39), p = 0.01; the respective median patient pain was 6 [4; 8] vs. 2 [1; 4], estimated difference -4.0 (95%CI, -5.8 to -2.3); p < 0.01.
US guidance by a trained physician significantly improves the rate of success in difficult radial ABGA patients.
Journal Article
Oral fluid supplementation for the prevention of post-dural puncture headache: A noninferiority randomized controlled trial
by
Dauvergne, Jérôme Emmanuel
,
Catinault, Marylène
,
Gazeau, Emmanuelle
in
Adult
,
Aged
,
Biology and Life Sciences
2025
To investigate the impact of the absence of specific advice for oral fluid intake, compared to supplementation water intake on the occurrence of post-dural puncture headache.
A prospective, open-label, non-inferiority, multicenter trial including hospitalized patients requiring a diagnostic lumbar puncture in seven hospitals in France.
Patients were randomly allocated (1:1) either to receive no specific advice on oral fluid intake (FREE-FLUID), or to be encouraged to drink 2 liters of water (CONTROL) within the 2 hours after lumbar puncture. The primary outcome was the post-dural puncture headache rate within the 5 days after lumbar puncture, with a non-inferiority margin of 10%. The secondary outcome was the time-to-post-dural puncture headache onset between Day 0 and Day 5.
From November 2016 and July 2019, we have included 554 participants. The primary outcomes occurs in 33.1% patients in the FREE-FLUID group, versus 38.0% in the CONTROL group with adjusted difference of 3.7%.
Among patients who had lumbar puncture, our study shows the noninferiority of the absence of specific advice on water intake after a lumbar puncture, compared with advice to increase oral fluid to prevent a post-dural puncture headache.
The value of questioning the appropriateness of non-evidence-based nursing care may allow time to be devoted to more relational and comforting care.
The study adheres to the CONSORT reporting guidelines.
No patient or public contribution.
Clinical Trials.gov (NCT02859233, August 9, 2016).
Journal Article
Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial
by
Suh, Jung-Won
,
Youn, Tae-Jin
,
Han, Donghoon
in
Access control
,
Acute coronary syndromes
,
Aged
2017
Arterial access and hemostasis are important processes during percutaneous coronary procedures. In this study, we tested if the use of chitosan-based pads on top of compression devices could improve hemostasis efficacy compared with compression devices alone after transradial coronary angiography or interventions.
This study was a single-center open-label randomized controlled trial. Patients who underwent coronary angiography or intervention with the transradial approach were randomly assigned to the study (compression device and a chitosan-based pad) or control (compression devices alone) group in a 2:1 fashion. The primary endpoint was time to hemostasis, categorized into ≤5, 6-10, 11-20, and >20 minutes.
Between April and July 2016, 95 patients were enrolled (59 were assigned to the study arm and 36 to the control arm). Time to hemostasis, the primary endpoint, was significantly lower in the study group than in the control group (p<0.001). Both groups showed low rates of vascular complications.
This study suggests that the use of a hemostasis pad in combination with rotatory compression devices is a safe and effective hemostasis strategy after radial artery access.
ClinicalTrials.gov NCT02954029.
Journal Article