A Phase 4 interventional study of Intravenous Dexamethasone and Normal Saline Placebo in Postoperative Pain, Arthroscopic Shoulder Surgery and Regional Anesthesia, sponsored by Gaziantep City Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Gaziantep City Hospital · Phase 4, Interventional, and Treatment
Among 148 studies testing dexamethasone in Pain, Postoperative — 27 open to participants now, 30 under way, 2 of them phase 3. Dexamethasone · Pain, Postoperative.
Among the 148 studies testing dexamethasone in Pain, Postoperative, this one is the 91st largest by planned enrollment, is one of 17 that started in 2026, is one of 75 in phase 4, reaches primary completion later than 17 of the 29 other live ones, and was the 138th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 70 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →27 of the 148 studies testing dexamethasone in Pain, Postoperative are open now, in 8 countries. Each count lists the studies.
Dexamethasone: first FDA approval 1958 (DECADRON), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →148 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 17 started in 2026.
Median enrollment 89 across the 148 interventional studies. Of the 96 that completed or were terminated, 22 (23%) have results posted.
1 of 148 have an industry lead sponsor. The 10 most frequent:
Gaziantep City Hospital is the lead sponsor of 21 studies on the registry; 14 are open to participants now.
Gaziantep City Hospital has 4 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
11 of the studies testing dexamethasone in Pain, Postoperative that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07413055Phase 3Oman Ministry of HealthComparative Efficacy Of 4 mg VS. 8 mg Submucosal Dexamethasone In Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial | 2026-11-15 |
| NCT07847047Phase 3Assiut UniversitySafety and Efficacy of Dexamethasone Versus Dexmedetomidine as Adjuvants in PENG Block in Hip Surgeries for Postoperative Pain Management | 2027-10 |
| NCT07795281Gaziantep City HospitalIntravenous Dexamethasone Added to Dexmedetomidine After Superior Trunk Block | 2026-12 |
| NCT07380139Ain Shams UniversityDexamethasone vs Dexmedetomidine in Sphenopalatine Ganglion Block for Rhinoplasty Pain | 2026-12-01 |
| NCT07672873Marmara UniversityLocal Dexamethasone Administration in Symptomatic Irreversible Pulpitis | 2026-12-15 |
Among the 148 studies testing dexamethasone in Pain, Postoperative, from their registry updates:
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.
Effective postoperative analgesia after arthroscopic shoulder surgery is important for patient comfort, early mobilization, and reduction of postoperative complications. Interscalene brachial plexus block is widely used for shoulder surgery; however, it may be associated with hemidiaphragmatic paresis and respiratory complications. Superior trunk block has been proposed as an alternative regional anesthesia technique that may provide effective analgesia with a potentially lower risk of respiratory impairment.
Adjuvant agents are frequently used to prolong the duration and improve the quality of analgesia after peripheral nerve blocks. Intravenous dexamethasone has been shown to prolong analgesia and improve postoperative pain control. Dexmedetomidine is another adjuvant agent with sedative and analgesic properties. However, evidence regarding the combined use of intravenous dexamethasone and intravenous dexmedetomidine in patients receiving superior trunk block for arthroscopic shoulder surgery is limited.
This study is designed as a prospective, randomized, placebo-controlled, triple-blind clinical trial. Adult patients aged 18 to 65 years, classified as American Society of Anesthesiologists physical status I to III, scheduled for elective arthroscopic shoulder surgery, and eligible for superior trunk block will be included after written informed consent.
All patients will receive standard monitoring before block placement. Premedication with intravenous midazolam may be administered for anxiolysis. A superficial cervical plexus block will be performed with 3 mL of 0.5% bupivacaine, followed by ultrasound-guided superior trunk block using 15 mL of 0.5% bupivacaine. Block success will be assessed approximately 20 minutes after block completion using sensory and motor evaluation.
Participants will be randomly assigned to one of two groups using a computer-generated randomization sequence and sealed opaque envelopes. In the intervention group, patients will receive standard intravenous dexmedetomidine infusion plus intravenous dexamethasone 0.15 mg/kg. In the control group, patients will receive standard intravenous dexmedetomidine infusion plus an equal volume of 0.9% normal saline placebo. The study drug or placebo will be prepared by an independent staff member who will not be involved in block performance, data collection, or outcome assessment. The patient, block practitioner, postoperative outcome assessor, and statistician will remain blinded to group allocation.
All patients will receive a standardized postoperative multimodal analgesia protocol. Intravenous ibuprofen 400 mg will be administered every 8 hours. Intravenous tramadol 50 mg will be used as rescue analgesia when the Numeric Rating Scale pain score is greater than 3 at rest or during passive movement, or when the patient requests additional analgesia. At least 4 hours will be allowed between tramadol doses, and the maximum daily tramadol dose will be limited to 400 mg.
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. Secondary outcomes include sensory and motor block characteristics, postoperative Numeric Rating Scale pain scores at 4, 8, 12, 24, and 72 hours, incidence of rebound pain, cumulative opioid consumption during the first 24 hours, perioperative blood glucose levels, hemodynamic events requiring treatment, postoperative nausea and vomiting, sleep disturbance due to pain during the first two nights, transient block-related complications such as Horner syndrome, hoarseness or dyspnea, and patient satisfaction at postoperative 72 hours.
Inclusion Criteria: Patients aged 18 to 65 years. Patients classified as physical status I to III.
Patients scheduled for elective arthroscopic shoulder surgery. Patients with a between 18.5 and 35 kg/m². Patients who are able to understand the study protocol and provide written .
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Exclusion Criteria: Patients younger than 18 years or older than 65 years. Patients classified as American Society of Anesthesiologists physical status IV or higher.
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.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Intravenous dexmedetomidine 0.5 mcg/kg will be administered as a 30-minute infusion to all participants in both study groups.
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.
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.
Time frame: 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
Postoperative pain scores
Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale at rest and during passive movement. Higher scores indicate greater pain intensity.
Time frame: T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour
Incidence of rebound pain
Rebound pain will be defined as a sudden increase in pain intensity to a Numeric Rating Scale score greater than 7 after resolution of the nerve block.
Time frame: T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour
Cumulative opioid consumption
Cumulative opioid consumption during the first 24 postoperative hours will be calculated and recorded as oral morphine equivalent dose in milligrams.
Time frame: During the first 24 hours postoperatively.
Blood glucose levels
Blood glucose levels will be measured to evaluate the systemic metabolic effect of intravenous dexamethasone.
Time frame: T1: postoperative 1st hour T2: postoperative 4th hour.
Hemodynamic events requiring treatment
The incidence of bradycardia and hypotension requiring pharmacologic treatment will be recorded. Bradycardia and hypotension will be treated according to the study protocol.
Time frame: T0: Perioperative 15th minute T1: Perioperative 60th minute T2: Postoperative 4th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour
Patient satisfaction
Patient satisfaction with the anesthesia and block technique will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Time frame: At postoperative 72 hours.
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be publicly shared due to patient confidentiality, institutional data protection policies, and the clinical nature of the collected perioperative data.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Gaziantep City Hospital