Intravenous Dexamethasone as an Adjuvant to Dexmedetomidine After Superior Trunk Block for Arthroscopic Shoulder Surgery

NCT07525934 | Not Yet Recruiting

• 1 other identifier: GZŞH-ANES-STB-DEXA
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate whether adding intravenous dexamethasone to standard intravenous dexmedetomidine improves pain control after shoulder arthroscopy performed under a superior trunk block. Shoulder arthroscopy is a common surgical procedure that can cause moderate to severe postoperative pain. In this study, adult patients undergoing elective arthroscopic shoulder surgery will receive a nerve block called a superior trunk block to control pain during and after surgery. All participants will also receive intravenous dexmedetomidine, a medication commonly used to enhance analgesia. Participants will be randomly assigned to one of two groups. One group will receive intravenous dexamethasone, while the other group will receive a placebo (saline solution). Neither the patients nor the healthcare providers nor the outcome assessors will know which treatment each participant receives. The main goal of the study is to determine how long it takes before patients require their first additional pain medication after surgery. Secondary outcomes include pain scores, total pain medication use, duration of nerve block, rebound pain, side effects, and patient satisfaction. The findings of this study may help improve postoperative pain management strategies for patients undergoing shoulder arthroscopy.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesic request

  Time from completion of the superior trunk block to the first administration of rescue analgesia, defined as analgesic requirement for Numeric Rating Scale (NRS) \>3 or upon patient request.

  From completion of superior trunk block to first rescue analgesic request, up to 72 hours postoperatively

Secondary Outcomes (1)

• Rebound pain incidence

  Through 72 hours postoperatively

Study Arms (2)

Intravenous Dexamethasone Group

EXPERIMENTAL

Drug: Dexamethasone; Drug: Dexmedetomidine

Placebo Group

PLACEBO COMPARATOR

Drug: Dexmedetomidine; Drug: Sodium Chloride 0.9%

Interventions

Dexmedetomidine DRUG

Dexmedetomidine will be administered intravenously at a dose of 0,5 mcg/kg as a 30-minute infusion.

Intravenous Dexamethasone Group; Placebo Group

Sodium Chloride 0.9% DRUG

Normal saline (0.9% sodium chloride) will be administered intravenously as a placebo in a volume matched to the dexamethasone dose.

Placebo Group

Dexamethasone DRUG

Dexamethasone will be administered intravenously at a dose of 0.15 mg/kg before surgery.

Intravenous Dexamethasone 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:

• Age between 18 and 65 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective arthroscopic shoulder surgery
• Body mass index (BMI) between 18.5 and 35 kg/m²
• Ability to understand the study protocol and provide written informed consent

You may not qualify if:

• Refusal to participate or inability to provide informed consent Contraindications to peripheral nerve block (e.g., coagulopathy, infection at the injection site) Known allergy or hypersensitivity to study medications (dexamethasone, dexmedetomidine, or local anesthetics) Pregnancy or breastfeeding Chronic opioid use or opioid dependence Pre-existing neurological deficit involving the operative upper extremity Severe hepatic or renal dysfunction Uncontrolled diabetes mellitus Body mass index (BMI) \>35 kg/m² Infection at the planned block site Participation in another interventional clinical trial within the last 30 days

Sponsors & Collaborators

• Recep Karakaşoğlu: lead

Related Publications (1)

• 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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share