PECS II Block in Thoracic Outlet Decompression

NCT ID: NCT04471545

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2021-10-03

Brief 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.

Conditions

Thoracic Outlet Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Interventional group

Intervention arm: PECS II block with ropivacaine

Group Type: EXPERIMENTAL

Pectoral nerve block type II

Intervention Type: PROCEDURE

A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided

Control group

Control arm: PECS II block with placebo (saline)

Group Type: PLACEBO_COMPARATOR

Pectoral nerve block type II

Intervention Type: PROCEDURE

A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided

Interventions

Pectoral nerve block type II

A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with NTOS
• Selected for a trans-axillary thoracic outlet decompression (TATOD) by the TOS multidisciplinary workgroup.
• Fit for surgery, defined as ASA (American Society of Anesthesiologists) Classification of I, II or III.
• 18 years of age or older
• Sufficient in speaking and writing the Dutch language
• Normal liver and renal function
• Informed consent

Exclusion Criteria

• Patients with a history of TOD (Redo-surgery)
• Patients with ATOS or VTOS
• ASA ≥ 4
• Kidney or liver failure with contra-indication for NSAID or paracetamol
• Mental retardation
• Pregnancy
• Patients with chronic strong opioid use (>3 administrations per week or continuous transdermal therapy, longer than the last 3 months)
• Allergy to one or more medications used in the study including, ropivacaine, dexamethasone, propofol, sufentanil, succinylcholine, paracetamol, NSAID, morphine, granisetron
• Patients that have trouble expressing themselves in Dutch. Questionnaires are completed by the patients and checked by the nurses. The questionnaire is in Dutch. If there is a language barrier between the questionnaire, the patient or the health care worker, we believe the validity of the answers is questionable.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Joep Teijink

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

References

van den Broek RJC, Goeteyn J, Houterman S, Bouwman RA, Versyck BJB, Teijink JAW. Interpectoral-pectoserratus plane (PECS II) block in patients undergoing trans-axillary thoracic outlet decompression surgery; A prospective double-blind, randomized, placebo-controlled clinical trial. J Clin Anesth. 2022 Nov;82:110939. doi: 10.1016/j.jclinane.2022.110939. Epub 2022 Jul 27.

Reference Type: DERIVED

PMID: 35907370 (View on PubMed)

Other Identifiers

NL72737.100.20

Identifier Type: -

Identifier Source: org_study_id