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Intravenous Dexamethasone Added to Dexmedetomidine After Superior Trunk Block

ConditionsPostoperative PainArthroscopic Shoulder SurgeryRegional Anesthesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGaziantep City Hospital

About this trial

This prospective, randomized, placebo-controlled, triple-blind trial will evaluate the effect of adding intravenous dexamethasone to intravenous dexmedetomidine on postoperative analgesia after superior trunk block in adult patients undergoing elective arthroscopic shoulder surgery.

All participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. Participants will be randomly assigned to receive either intravenous dexamethasone or an equal volume of normal saline placebo before surgery. The main outcome will be the time from completion of the block to the first request for rescue analgesia after surgery.

The study will also evaluate postoperative pain scores, rebound pain, opioid consumption, blood glucose levels, hemodynamic changes, postoperative nausea and vomiting, sleep disturbance due to pain, block-related complications, and patient satisfaction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous Dexamethasone

    Drug

    Intravenous dexamethasone 0.15 mg/kg will be administered before surgery to participants assigned to the dexamethasone group, in addition to ultrasound-guided superior trunk block and standard intravenous dexmedetomidine infusion.

  • Normal Saline Placebo

    Drug

    An equal volume of 0.9% normal saline placebo will be administered before surgery to participants assigned to the placebo group, in addition to ultrasound-guided superior trunk block and standard intravenous dexmedetomidine infusion.

  • Intravenous Dexmedetomidine

    Drug

    Intravenous dexmedetomidine 0.5 mcg/kg will be administered as a 30-minute infusion to all participants in both study groups.

  • Superior Trunk Block

    Procedure/Surgery

    Ultrasound-guided superior trunk block will be performed in all participants using 15 mL of 0.5% bupivacaine before arthroscopic shoulder surgery. Block success will be assessed approximately 20 minutes after block completion.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Dexamethasone GroupExperimental treatment 3 interventions
Group B: Placebo GroupPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Time to first rescue analgesic request

The primary outcome is the time from completion of the superior trunk block to the first request for systemic rescue analgesia in the postoperative period. Rescue analgesia will be defined as intravenous tramadol administration when the Numeric Rating Scale pain score is greater than 3 at rest or during passive movement, or when the patient requests additional analgesia.

Time frame
First rescue analgesic request, assessed up to 72 hours postoperatively. T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour

Secondary outcomes

1

Postoperative pain scores

Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale at rest and during passive movement. Higher scores indicate greater pain intensity.

Time frame
T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour
2

Incidence of rebound pain

Rebound pain will be defined as a sudden increase in pain intensity to a Numeric Rating Scale score greater than 7 after resolution of the nerve block.

Time frame
T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour
3

Cumulative opioid consumption

Cumulative opioid consumption during the first 24 postoperative hours will be calculated and recorded as oral morphine equivalent dose in milligrams.

Time frame
During the first 24 hours postoperatively.
4

Blood glucose levels

Blood glucose levels will be measured to evaluate the systemic metabolic effect of intravenous dexamethasone.

Time frame
T1: postoperative 1st hour T2: postoperative 4th hour.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Gaziantep City Hospital

Lead sponsor

Source ClinicalTrials.gov

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