Postoperative PainPhase 4STB-DEXNCT07795281
Intravenous Dexamethasone Added to Dexmedetomidine After Superior Trunk Block
A Phase 4 study testing Intravenous Dexamethasone, Intravenous Dexmedetomidine and Superior Trunk Block in people with Postoperative Pain and Arthroscopic Shoulder Surgery, run by Gaziantep City Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Arthroscopic Shoulder Surgery, Regional Anesthesia
- What is being tested?
- Intravenous Dexamethasone, Intravenous Dexmedetomidine and Superior Trunk Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jan 2027
- Phase
- Phase 4
- 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
Inclusion Criteria: Patients aged 18 to 65 years. Patients classified as American Society of Anesthesiologists physical status I to III.
Patients scheduled for elective arthroscopic shoulder surgery. Patients with a body mass index between 18.5 and 35 kg/m². Patients who are able to understand the study protocol and provide written informed consent.
-
Exclusion Criteria: Patients younger than 18 years or older than 65 years. Patients classified as American Society of Anesthesiologists physical status IV or higher.
Contraindications 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.
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 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.
Read the detailed description
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.
- Being tested
- Intravenous Dexamethasone, Normal Saline Placebo, Intravenous Dexmedetomidine, Superior Trunk Block
- Keywords
- Superior trunk block, Arthroscopic shoulder surgery, Postoperative analgesia, Intravenous dexamethasone, Intravenous dexmedetomidine, Placebo-controlled trial, Randomized controlled trial, Triple-blind trial, Rebound pain, Numeric Rating Scale, Rescue analgesia, Peripheral nerve block, Bupivacaine, Opioid consumption, Patient satisfaction
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous DexamethasoneDrug
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.
Normal Saline PlaceboDrug
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 DexmedetomidineDrug
Intravenous dexmedetomidine 0.5 mcg/kg will be administered as a 30-minute infusion to all participants in both study groups.
Superior Trunk BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Experimental | 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. Receives: Drug: Intravenous Dexamethasone; Drug: Intravenous Dexmedetomidine; Procedure: Superior Trunk Block |
| Placebo Group | Placebo comparator | 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. Receives: Drug: Normal Saline Placebo; Drug: Intravenous Dexmedetomidine; Procedure: Superior Trunk Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: During the first 24 hours postoperatively.
Blood glucose levels
Blood glucose levels will be measured to evaluate the systemic metabolic effect of intravenous dexamethasone.
Measured: 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.
Measured: 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.
Measured: At postoperative 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups. All participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. The intervention group will receive intravenous dexamethasone 0.15 mg/kg, while the control group will receive an equal volume of 0.9% normal saline placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bekir Suat Kürkçüoğlu, MD, Principal investigator, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795281
- Sponsor's protocol ID
- GCH-STB-DEX-2026
- Acronym
- STB-DEX
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Et T, Basaran B, Bilge A, Yarimoglu R, Korkusuz M, Tuluce I. Rebound pain after interscalene brachial plexus block for shoulder surgery: a randomized clinical trial of the effect of different multimodal analgesia regimens. Ann Saudi Med. 2023 Nov-Dec;43(6):339-347. doi: 10.5144/0256-4947.2023.339. Epub 2023 Dec 7.
PubMed 38071444Kang RA, Jeong JS, Yoo JC, Lee JH, Gwak MS, Choi SJ, Hahm TS, Cho HS, Ko JS. Improvement in postoperative pain control by combined use of intravenous dexamethasone with intravenous dexmedetomidine after interscalene brachial plexus block for arthroscopic shoulder surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 May;36(5):360-368. doi: 10.1097/EJA.0000000000000977.
PubMed 30865001Kim 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 37775273Buyukgebiz Yesil B, Emmez G, Kanatli U, Oguzulgen IK, Gunaydin B, Gungor I. Impact of interscalene versus superior trunk blocks as sole anesthetics on respiratory outcomes for shoulder arthroscopy: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 14;26(1):106. doi: 10.1186/s12871-025-03575-0.
PubMed 41530734
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 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
- NCT07795281
- Acronym / sponsor ID
- STB-DEX / GCH-STB-DEX-2026
- Keywords
- Superior trunk block, Arthroscopic shoulder surgery, Postoperative analgesia, Intravenous dexamethasone, Intravenous dexmedetomidine, Placebo-controlled trial, Randomized controlled trial, Triple-blind trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 31 Aug 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. All participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. The intervention group will receive intravenous dexamethasone 0.15 mg/kg, while the control group will receive an equal volume of 0.9% normal saline placebo.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group | Experimental | Drug: Intravenous Dexamethasone, Drug: Intravenous Dexmedetomidine, Procedure: Superior Trunk BlockParticipants 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. |
| Placebo Group | Placebo comparator | Drug: Normal Saline Placebo, Drug: Intravenous Dexmedetomidine, Procedure: Superior Trunk BlockParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intravenous DexamethasoneIntravenous 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. | Drug | Dexamethasone Group |
| Normal Saline PlaceboAn 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. | Drug | Placebo Group |
| Intravenous DexmedetomidineIntravenous dexmedetomidine 0.5 mcg/kg will be administered as a 30-minute infusion to all participants in both study groups. | Drug | Dexamethasone Group, Placebo Group |
| Superior Trunk BlockUltrasound-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. | Procedure or surgery | Dexamethasone Group, Placebo Group |
Primary outcome
Time to first rescue analgesic request
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
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.
6 secondary outcomes
Postoperative pain scores
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
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
Time frame: During the first 24 hours postoperatively.
Blood glucose levels
Time frame: T1: postoperative 1st hour T2: postoperative 4th hour.
Hemodynamic events requiring treatment
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
Time frame: At postoperative 72 hours.
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 31 Aug 2026.
- Background: PubMed 38071444Et T, Basaran B, Bilge A, Yarimoglu R, Korkusuz M, Tuluce I. Rebound pain after interscalene brachial plexus block for shoulder surgery: a randomized clinical trial of the effect of different multimodal analgesia regimens. Ann Saudi Med. 2023 Nov-Dec;43(6):339-347. doi: 10.5144/0256-4947.2023.339. Epub 2023 Dec 7.
- Background: PubMed 30865001Kang RA, Jeong JS, Yoo JC, Lee JH, Gwak MS, Choi SJ, Hahm TS, Cho HS, Ko JS. Improvement in postoperative pain control by combined use of intravenous dexamethasone with intravenous dexmedetomidine after interscalene brachial plexus block for arthroscopic shoulder surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 May;36(5):360-368. doi: 10.1097/EJA.0000000000000977.
- 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.
- Background: PubMed 41530734Buyukgebiz Yesil B, Emmez G, Kanatli U, Oguzulgen IK, Gunaydin B, Gungor I. Impact of interscalene versus superior trunk blocks as sole anesthetics on respiratory outcomes for shoulder arthroscopy: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 14;26(1):106. doi: 10.1186/s12871-025-03575-0.
- Individual participant dataSharing planned: 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.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Bekir Suat Kürkçüoğlu, MD principal investigator
Gaziantep City Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Dexamethasone, Intravenous Dexmedetomidine and Superior Trunk Block in people with Postoperative Pain and Arthroscopic Shoulder Surgery, run by Gaziantep City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Bekir Suat Kürkçüoğlu, MD (+90 505 583 04 63, bekirsuat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesic request (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). 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 NCT07795281, which also lists 4 linked publications.
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 31 Aug 2026.