Health TrialsbyHealthPanel

Prevention of Rebound Pain After Axillary Block

ConditionsPainPostoperative Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Tunis El Manar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

- 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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Axillary Plexus Block with dexametasoneActive comparator 1 intervention
Group B: Axillary Plexus Block controlPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
1 hour postoperatively to 48 hours postoperatively

Secondary outcomes

1

Pain score at rest

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

Time frame
hour 1, hour 48 postoperative
2

Pain score at movement

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

Time frame
hour 1, hour 48 postoperative
3

The analgesic consumption

The number of rescue analgesic dose during the first 24 hours

Time frame
hour 1, hour 24 postoperatively
4

Duration of motor block

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

Time frame
hour 1 postoperatively, 12 hours after nerve block

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Tunis El Manar

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: