- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07784426
Tourniquet Pain Prevention During Distal Upper Limb Surgery
August 25, 2026 updated by: Zagazig University
Brachial Plexus With Intercostobrachial Nerve or Serratus Anterior Plane Block for Tourniquet Pain Prevention During Distal Upper-Limb Surgery
Post-tourniquet pain remains a common problem.
It disturbs the quality of anesthesia during brachial plexus block for distal upper-limb surgery.
Current evidence shows that adding an intercostobrachial nerve block using the landmark-based technique can improve analgesia for medial upper-arm procedures.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Post-tourniquet pain remains a common problem.
It disturbs the quality of anesthesia during brachial plexus block for distal upper-limb surgery.
Current evidence shows that adding an intercostobrachial nerve block using the landmark-based technique can improve analgesia for medial upper-arm procedures.
The serratus anterior plane block has also been proposed as an adjunct that may cover the intercostobrachial nerve territory.
However, the landmark intercostobrachial nerve technique relies on a blind injection and may give inconsistent results.
Moreover, high-quality head-to-head data comparing ultrasound-guided intercostobrachial nerve block with serratus anterior plane block for tourniquet pain prevention are lacking.
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Mohamed, MD
- Phone Number: 01 203350873
- Email: mgmelsayed@medicine.zu.edu.eg
Study Contact Backup
- Name: Ahmed Mohamed Hassan
- Phone Number: +20 11 13930038
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Elective unilateral distal upper-limb surgery (hand, wrist or forearm) with use of pneumatic upper-arm tourniquets under ultrasound-guided brachial plexus block.
Exclusion Criteria:
- Coagulopathy or therapeutic anticoagulation.
- Local infection at injection sites.
- Chronic opioid dependence.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Selective ultrasound guided Intercostobrachial nerve block
After a brachial plexus block, participants will receive a selective Intercostobrachial nerve block.
The patient will be positioned supine with the ipsilateral arm abducted.
The ultrasound transducer will be positioned in the axilla along the mid-axillary line to visualize the thoracodorsal artery and vein and the fascia between the latissimus dorsi and serratus anterior muscles.
|
The patient will be positioned supine with the ipsilateral arm abducted.
The ultrasound transducer will be positioned in the axilla along the mid-axillary line to visualize the thoracodorsal artery and vein and the fascia between the latissimus dorsi and serratus anterior muscles.
The Intercostobrachial nerve often appears as a small hyperechoic structure lateral to the thoracodorsal vessels.
|
|
Active Comparator: Serratus anterior plane block
The patient will be positioned supine with the ipsilateral arm abducted slightly.
Under aseptic conditions, the ultrasound transducer will be placed at the mid-axillary line at the level of the fourth or fifth rib to identify the plane between the latissimus dorsi and serratus anterior muscles.
|
The ultrasound transducer will be placed at the mid-axillary line at the level of the fourth or fifth rib to identify and inject a local anaesthetic drug in the plane between the latissimus dorsi and serratus anterior muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tourniquet pain degree
Time Frame: The first 60 minutes of tourniquet inflation.
|
The visual analogue score of tourniquet pain at the end of first 60 minutes of tourniquet inflation with score 10 indicates worst pain and score 0 indicates no pain.
|
The first 60 minutes of tourniquet inflation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of tourniquet application.
Time Frame: The first 2 hours intraoperative.
|
The time from tourniquet inflation to tourniquet deflation.
|
The first 2 hours intraoperative.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amal Abdelazim Salah, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
- Study Chair: Osama Abo Elfotouh Ismael Hassan, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
August 21, 2026
First Submitted That Met QC Criteria
August 21, 2026
First Posted (Actual)
August 25, 2026
Study Record Updates
Last Update Posted (Actual)
August 27, 2026
Last Update Submitted That Met QC Criteria
August 25, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tourniquet Pain Management
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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