PECS II Block in Thoracic Outlet Decompression

Status Completed

Clinical Trial Summary

Rationale: Postoperative pain management after transaxillary thoracic outlet decompression surgery (TATOD) is difficult. In a retrospective case-control trial, we found evidence that a PECS II block is able to reduce pain and morphine consumption. This may ultimately lead to less morphine induced side-effects and improved patient satisfaction. However, the risk of bias in retrospective research is high. To determine the effect of PECS II in TATOD, a randomized controlled double blinded trial could offer more valuable scientific evidence. Our hypothesis is that a PECS II block will reduce pain, opioid use and opioid induced side-effects in patients undergoing transaxillary TOD (TATOD). Objective: The aim of the study is to determine the effect of a PECS II block on postoperative pain and opioid use in patients undergoing TATOD. The secondary objective is to determine the effect of a PECS II block on opioid induced side effects such as postoperative nausea and vomitus and the quality of recovery Study design: Single centre randomized controlled double blinded trial Study population: All patients with Neurogenic Thoracic Outlet Syndrome (NTOS) selected for TATOD by the TOS multidisciplinary workgroup and based on the specifications in 2016 SVS reporting standards. Intervention: The study group will receive a PECS II block with 40 ml ropivacaine 5 mg/ml. The control group will receive a PECS II block with 40 ml NaCL 0.9%. Main study parameters/endpoints: Primary outcome parameters are postoperative pain using the Numeric Rated Scale (NRS) score assessed at rest and when moving and postoperative morphine-equivalent consumption. Secondary outcome parameters are postoperative Nausea and Vomitus (PONV) and Quality of Recovery questionnaire (QoR-15). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will undergo ultrasound guided injection, after induction of anaesthesia. The administration of the injection does not invoke any extra physical discom-fort. Possible complications include hematoma and pneumothorax, however, the risk is very low (<1%)[1]. In the intervention group, we expect less pain, a reduced need for pain medica-tion and less postoperative nausea and vomitus. We do not expect an altered postoperative course in the control group. Patients will be asked to fill out a questionnaire. Extra blood sam-ples, site visits, physical examinations or other test will not be done in this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Thoracic Outlet Syndrome

Clinical Trial Details

NCT number	NCT04471545
Study type	Interventional
Source	Catharina Ziekenhuis Eindhoven
Contact
Status	Completed
Phase	N/A
Start date	August 27, 2020
Completion date	October 3, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PECS II Block in Thoracic Outlet Decompression — BLOCKTOS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms