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NCT Number: NCT07313553

Prevention of Rebound Pain After Axillary Block

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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probe.It was advanced toward the musculocutaneous nerve (MCN) and local anesthetic was injected.Then, the needle was retracted and redirected deep relative to the axillary artery and local anesthetic was injectedaround the posterior aspect of the axillary artery and finallythe needle was retracted and redirected superficial to the axillary artery and local anesthetic was injected.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Other

2 ml saline solution are added to 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%

Dexamathsone 4mg/ml associated with experimental arm

Drug

Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.

Primary outcomes

  1. incidence of Rebound pain

    Time frame: 1 hour postoperatively to 48 hours postoperatively

    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.

Secondary outcomes

  1. Pain score at rest

    Time frame: hour 1, hour 48 postoperative

    Pain score at rest using NRS [Numerical Rate Scale from 0 no pain to 10 worst pain

  2. Pain score at movement

    Time frame: hour 1, hour 48 postoperative

    Pain scores at mouvement using NRS [Numerical Rate Scale from 0 no pain to 10 worst pain

  3. The analgesic consumption

    Time frame: hour 1, hour 24 postoperatively

    The number of rescue analgesic dose during the first 24 hours

  4. Duration of motor block

    Time frame: hour 1 postoperatively, 12 hours after nerve block

    The end of motor block was defined by a total flexion of fingers and arm.

  5. Blood glucose level

    Time frame: after nerve block, 24 hours after surgery

    level of glucose in serum blood

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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