Intravenous Dexamethasone Added to Dexmedetomidine After Superior Trunk Block

NCT07795281 | Not Yet Recruiting Phase 4

• 1 other identifier: GCH-STB-DEX-2026
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Arthroscopic Shoulder Surgery; Regional Anesthesia

Keywords

Superior trunk block; Arthroscopic shoulder surgery; Postoperative analgesia; Intravenous dexamethasone; Intravenous dexmedetomidine; Placebo-controlled trial; Randomized controlled trial; Triple-blind trial; Rebound pain; Numeric Rating Scale; Rescue analgesia; Peripheral nerve block; Bupivacaine; Opioid consumption; Patient satisfaction

Outcome Measures

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.

  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 (6)

• Postoperative pain scores

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

• Incidence of rebound pain

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

• Cumulative opioid consumption

  During the first 24 hours postoperatively.

• Blood glucose levels

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

• Hemodynamic events requiring treatment

  T0: Perioperative 15th minute T1: Perioperative 60th minute T2: Postoperative 4th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour

Study Arms (2)

Dexamethasone Group

EXPERIMENTAL

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.

Drug: Intravenous Dexamethasone; Drug: Intravenous Dexmedetomidine; Procedure: Superior Trunk Block

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Normal Saline Placebo; Drug: Intravenous Dexmedetomidine; Procedure: Superior Trunk Block

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.

Dexamethasone Group

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.

Placebo Group

Intravenous Dexmedetomidine DRUG

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

Dexamethasone Group; Placebo Group

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.

Dexamethasone Group; Placebo Group

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for elective arthroscopic shoulder surgery. Patients with a body mass index between 18.5 and 35 kg/m². Patients who are able to understand the study protocol and provide written informed consent.

You may not qualify if:

• Contraindications to peripheral nerve block, including coagulopathy or infection at the block site.
• Known allergy or contraindication to any of the drugs used in the study. Active gastrointestinal bleeding, history of peptic ulcer disease, or severe renal or hepatic insufficiency.
• History of chronic analgesic or opioid use. Pregnancy or breastfeeding. Presence of coagulopathy or use of anticoagulant or antiplatelet therapy. Requirement for additional sedation or general anesthesia during surgery. Neurological or psychiatric disease that may affect pain assessment.

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Related Publications (4)

• Et T, Basaran B, Bilge A, Yarimoglu R, Korkusuz M, Tuluce I. Rebound pain after interscalene brachial plexus block for shoulder surgery: a randomized clinical trial of the effect of different multimodal analgesia regimens. Ann Saudi Med. 2023 Nov-Dec;43(6):339-347. doi: 10.5144/0256-4947.2023.339. Epub 2023 Dec 7.

  PMID: 38071444 BACKGROUND

• Kang RA, Jeong JS, Yoo JC, Lee JH, Gwak MS, Choi SJ, Hahm TS, Cho HS, Ko JS. Improvement in postoperative pain control by combined use of intravenous dexamethasone with intravenous dexmedetomidine after interscalene brachial plexus block for arthroscopic shoulder surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 May;36(5):360-368. doi: 10.1097/EJA.0000000000000977.

  PMID: 30865001 BACKGROUND

• Kim Y, Yoo S, Kim SH, Kim H, Bae J, Park SK, Kim JT, Lim YJ. Comparison between low-volume local anesthetic with intravenous dexamethasone and conventional volume without dexamethasone for superior trunk block after arthroscopic shoulder surgery: a randomized controlled non-inferiority trial. Reg Anesth Pain Med. 2024 Aug 5;49(8):558-564. doi: 10.1136/rapm-2023-104520.

  PMID: 37775273 BACKGROUND

• Buyukgebiz Yesil B, Emmez G, Kanatli U, Oguzulgen IK, Gunaydin B, Gungor I. Impact of interscalene versus superior trunk blocks as sole anesthetics on respiratory outcomes for shoulder arthroscopy: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 14;26(1):106. doi: 10.1186/s12871-025-03575-0.

  PMID: 41530734 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bekir Suat Kürkçüoğlu, MD

  Gaziantep City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bekir Suat Kürkçüoğlu, MD

CONTACT

+90 505 583 04 63; bekirsuat@gmail.com

Sinan Ünsal, MD

CONTACT

+90 5380537502; sinannsal93@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blind trial. The study drug or placebo will be prepared by an independent staff member who will not participate in block performance, intraoperative care, postoperative data collection, or statistical analysis. Participants, the anesthesiologist performing the block and administering the study syringe, and the postoperative outcome assessor will be blinded to group allocation. Statistical analysis will be performed using coded groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups. All participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. The intervention group will receive intravenous dexamethasone 0.15 mg/kg, while the control group will receive an equal volume of 0.9% normal saline placebo.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share