Prevention of Rebound Pain After Axillary Block

NCT07313553 | Not Yet Recruiting

• 1 other identifier: IMKO-CE-2023-004
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain; Postoperative Care

Keywords

axillary nerve block; dexamethesone; rebound pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain score at rest

  hour 1, hour 48 postoperative

• Pain score at movement

  hour 1, hour 48 postoperative

• The analgesic consumption

  hour 1, hour 24 postoperatively

• Duration of motor block

  hour 1 postoperatively, 12 hours after nerve block

• Blood glucose level

  after nerve block, 24 hours after surgery

Study Arms (2)

Axillary Plexus Block with dexametasone

ACTIVE COMPARATOR

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

Axillary Plexus Block control

PLACEBO COMPARATOR

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

Interventions

Saline OTHER

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

Axillary Plexus Block control

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.

Axillary Plexus Block with dexametasone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Tunis El Manar: lead

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12