Intravenous Dexamethasone Added to Dexmedetomidine After Superior Trunk Block

Sponsor
Gaziantep City Hospital
Study ID
NCT07795281
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Arthroscopic Shoulder Surgery
  • Postoperative Pain
  • Regional Anesthesia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dexamethasone Group
    Participants in this arm will receive ultrasound-guided superior trunk block with 15 mL of 0.5% bupivacaine and standard intravenous dexmedetomidine 0.5 mcg/kg as a 30-minute infusion. In addition, intravenous dexamethasone 0.15 mg/kg will be administered before surgery.
  • Placebo Comparator: Placebo Group
    Participants in this arm will receive ultrasound-guided superior trunk block with 15 mL of 0.5% bupivacaine and standard intravenous dexmedetomidine 0.5 mcg/kg as a 30-minute infusion. In addition, an equal volume of 0.9% normal saline placebo will be administered before surgery.

Primary Outcome Measure

Time to first rescue analgesic request [ 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 ]

Central Contacts

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