Prevention of Rebound Pain After Axillary Block
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saline, Dexamathsone 4mg/ml associated with experimental arm.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative Care. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Perineural Dexamethasone on Preventing Rebound Pain After Axillary Plexus Block in Hand Surgery
Overview
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.
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.
Interventions
- Other Saline
2 ml saline solution are added to 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% - 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.
Primary outcome measures
- incidence of Rebound pain [Time frame: 1 hour postoperatively to 48 hours postoperatively]
Secondary outcome measures (5)
- Pain score at rest [Time frame: hour 1, hour 48 postoperative]
- Pain score at movement [Time frame: hour 1, hour 48 postoperative]
- The analgesic consumption [Time frame: hour 1, hour 24 postoperatively]
- Duration of motor block [Time frame: hour 1 postoperatively, 12 hours after nerve block]
- Blood glucose level [Time frame: after nerve block, 24 hours after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07313553 · IMKO-CE-2023-004