Postoperative PainSTB-DEXANCT07525934
Intravenous Dexamethasone as an Adjuvant to Dexmedetomidine After Superior Trunk Block for Arthroscopic Shoulder Surgery
A study testing Dexamethasone, Dexmedetomidine and Sodium Chloride 0.9% in people with Postoperative Pain, run by Recep Karakaşoğlu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone, Dexmedetomidine and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2026to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read more
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
- Being tested
- Dexamethasone, Dexmedetomidine, Sodium Chloride 0.9%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone will be administered intravenously at a dose of 0.15 mg/kg before surgery.
DexmedetomidineDrug
Dexmedetomidine will be administered intravenously at a dose of 0,5 mcg/kg as a 30-minute infusion.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Dexamethasone Group | Experimental | Not described Receives: Drug: Dexamethasone; Drug: Dexmedetomidine |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Dexmedetomidine; Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From completion of superior trunk block to first rescue analgesic request, up to 72 hours postoperatively
Secondary outcomes (1)
Rebound pain incidence
Incidence of rebound pain, defined as severe pain with an NRS score of 7 or higher after block resolution.
Measured: Through 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start25 Apr 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Karakaşoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Recep Karakaşoğlu, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525934
- Sponsor's protocol ID
- GZŞH-ANES-STB-DEXA
- Acronym
- STB-DEXA
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37775273
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07525934
- Acronym / sponsor ID
- STB-DEXA / GZŞH-ANES-STB-DEXA
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Recep KarakaşoğluUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Dexamethasone Group | Experimental | Drug: Dexamethasone, Drug: Dexmedetomidine |
| Placebo Group | Placebo comparator | Drug: Dexmedetomidine, Drug: Sodium Chloride 0.9% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone will be administered intravenously at a dose of 0.15 mg/kg before surgery. | Drug | Intravenous Dexamethasone Group |
| DexmedetomidineDexmedetomidine will be administered intravenously at a dose of 0,5 mcg/kg as a 30-minute infusion. | Drug | Intravenous Dexamethasone Group, Placebo Group |
| 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. | Drug | Placebo Group |
Primary outcome
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.
1 secondary outcome
Rebound pain incidence
Time frame: Through 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 37775273Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone, Dexmedetomidine and Sodium Chloride 0.9% in people with Postoperative Pain, run by Recep Karakaşoğlu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesic request (time frame: From completion of superior trunk block to first rescue analgesic request, up to 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07525934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.