Intravenous Dexamethasone as an Adjuvant to Dexmedetomidine After Superior Trunk Block for Arthroscopic Shoulder Surgery (STB-DEXA)

April 7, 2026 updated by: Recep Karakaşoğlu

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Group
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.
Experimental: Intravenous Dexamethasone Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesic request
Time Frame: From completion of superior trunk block to first rescue analgesic request, up to 72 hours postoperatively
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rebound pain incidence
Time Frame: Through 72 hours postoperatively
Incidence of rebound pain, defined as severe pain with an NRS score of 7 or higher after block resolution.
Through 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Recep Karakaşoğlu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GZŞH-ANES-STB-DEXA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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