Prevention of Rebound Pain After Axillary Block

The Effect of Perineural Dexamethasone on Preventing Rebound Pain After Axillary Plexus Block in Hand Surgery

This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Postoperative Care
• Intervention / Treatment: Drug: Dexamathsone 4mg/ml associated with experimental arm; Other: Saline

Detailed Description

After the arrival to the operation room, monitoring including pulse oximetry, electrocardiogram, and noninvasive blood pressure was applied.

An 18 or 16-gauge IV cannula was inserted and Ringer's lactate infusion was started at a rate of 5 mL per kg per hour.

Antibioprophylaxis was systematically administered with 2 grams ofCefazolin 30 minutes before induction.

All patients were given an ultrasound-guided single-injection axillary plexus block by experienced anesthesiologists.

Sedation with 2 mg midazolam intravenously before block was administered.

In the group Dexamethasone (D), patients received axillary plexus block with a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.

In the group control (X), patients received a 30 mlof a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% containing 2 ml saline solution.

For the axillary plexus block, patients were placed in a supine positionwith the arm in 90° of abduction and the forearm in flexion.A high frequency linear probe was placed on the transverse axis, over the axillary fold.The axillary artery, vein, and nerves surrounding the artery were visualized after scanning distally and proximally. The block needle (50 mm, 22G) was inserted in-plane from anterior to posterior, parallel to the ultrasound probe.It was advanced toward the musculocutaneous nerve (MCN) and local anesthetic was injected.Then, the needle was retracted and redirected deep relative to the axillary artery and local anesthetic was injectedaround the posterior aspect of the axillary artery and finallythe needle was retracted and redirected superficial to the axillary artery and local anesthetic was injected.

Before the surgical incision, the effectiveness of the sensory blockade of the axillary plexus was evaluated by a cold test in the different territories.

Post-operatively, all patients were put on systematic paracetamol 1 g every 6 hours, without exceeding 4 grams per day.

when the postoperative pain score (NRS) was >3/10, intravenous tramadol 100 mg was administered.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Age between 18 and 75 years old.

  • Patients are current for hand surgery under axillary plexus block.
  • Patients classified ASA physical status I, II and III

Exclusion Criteria:

• - Contraindication to regional anesthesia.
• Patient's disapproval.
• Impaired cognition.
• Patients whose surgery must be done under general anesthesia (complex hand surgery or association of other)
• Allergy to paracetamol, dexamethasone or opioids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Axillary Plexus Block with dexametasone; In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.	Drug: Dexamathsone 4mg/ml associated with experimental arm; Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
Placebo Comparator: Axillary Plexus Block control; In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 2 mL of saline solution.	Other: Saline; 2 ml saline solution are added to 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Rebound pain	The primary objective is the incidence of rebound pain, which was defined as severe pain (NRS ≥ 7) [Numerical rate scale from 0 no pain to 10 worst pain] at the surgical site during the first 48 hours postoperatively.	1 hour postoperatively to 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score at rest	Pain score at rest using NRS [Numerical Rate Scale from 0 no pain to 10 worst pain	hour 1, hour 48 postoperative
Pain score at movement	Pain scores at mouvement using NRS [Numerical Rate Scale from 0 no pain to 10 worst pain	hour 1, hour 48 postoperative
The analgesic consumption	The number of rescue analgesic dose during the first 24 hours	hour 1, hour 24 postoperatively
Duration of motor block	The end of motor block was defined by a total flexion of fingers and arm.	hour 1 postoperatively, 12 hours after nerve block
Blood glucose level	level of glucose in serum blood	after nerve block, 24 hours after surgery

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Estimated): January 12, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: axillary nerve block; rebound pain; dexamethesone
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: IMKO-CE-2023-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No