Intravenous Dexamethasone as an Adjuvant to Dexmedetomidine After Superior Trunk Block for Arthroscopic Shoulder Surgery
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: Dexamethasone, Dexmedetomidine, Sodium Chloride 0.9%.
- Who it may be relevant to
- Registry conditions: Postoperative Pain. Basic parameters: 18 years — 65 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 →
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Official title
Effect of Intravenous Dexamethasone Added to Intravenous Dexmedetomidine on Postoperative Analgesia After Superior Trunk Block for Arthroscopic Shoulder Surgery: A Prospective, Randomized, Placebo-Controlled, Triple-Blind Trial
Overview
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.
Interventions
- Drug Dexamethasone
Dexamethasone will be administered intravenously at a dose of 0.15 mg/kg before surgery. - Drug Dexmedetomidine
Dexmedetomidine will be administered intravenously at a dose of 0,5 mcg/kg as a 30-minute infusion. - Drug Sodium Chloride 0.9%
Normal saline (0.9% sodium chloride) will be administered intravenously as a placebo in a volume matched to the dexamethasone dose.
Primary outcome measures
- Time to first rescue analgesic request [Time frame: From completion of superior trunk block to first rescue analgesic request, up to 72 hours postoperatively]
Secondary outcome measures (1)
- Rebound pain incidence [Time frame: Through 72 hours postoperatively]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
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
- Triple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT07525934 · GZŞH-ANES-STB-DEXA