Post Operative Pain, AcutePhase 4NCT07292324
Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy
A Phase 4 study testing Dexmedetomidine & Bupivacaine. and Bupivacain in people with Post Operative Pain, Acute and Chronic Post Surgical Pain, run by Udayana University at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if adding a medication called dexmedetomidine to an epidural block works better than a standard epidural to control pain in women undergoing gynecologic laparotomy (abdominal surgery). Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Post Operative Pain, Acute, Chronic Post Surgical Pain, Gynecologic Disease
- What is being tested?
- Dexmedetomidine & Bupivacaine. and Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Aug 2025to 15 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 30-55 years
- ASA physical status I-III
- Body Mass Index (BMI) 18 - 29.9 kg/m2
- Patients undergoing gynecologic laparotomy
Who cannot join
- Contraindications for regional anesthesia
- Allergy or contraindication to dexmedetomidine
- Routine use of antidepressants or anticonvulsants
- Chronic opioid consumption (equivalent to >30 mg oral morphine per day for >1 month)
- History of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- Active systemic autoimmune disease or receiving immunosuppressant therapy (e.g., Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis)
Show all 9Show fewer
- Inability to use the Visual Analogue Scale (VAS) or operate the Patient-Controlled Epidural Analgesia (PCEA) device
- Coagulation disorders (prolonged hemostasis)
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Prof. Dr. I.G.N.G Ngoerah Central General Hospital
Denpasar, Bali, 80114
About this study
Official title: Effectiveness of Continuous Epidural With Dexmedetomidine Adjuvant Compared to Without Adjuvant in Gynecologic Laparotomy
The goal of this clinical trial is to learn if adding a medication called dexmedetomidine to an epidural block works better than a standard epidural to control pain in women undergoing gynecologic laparotomy (abdominal surgery). The main questions it aims to answer are:
Does adding dexmedetomidine reduce pain scores and the need for extra pain medicine in the first 24 hours after surgery? Does it lower inflammation levels and reduce the risk of developing chronic pain 3 months later?
Read more
Participants will receive an epidural (pain medicine delivered through a small tube in the back) combined with general anesthesia for their surgery. Researchers will compare two groups:
One group will receive the standard epidural medicine (bupivacaine) mixed with dexmedetomidine.
The other group will receive the standard epidural medicine (bupivacaine) alone.
Researchers will measure the participants' pain levels, how much pain medicine they use, and blood markers for inflammation for 24 hours after surgery. They will also contact participants 3 months later to check for any long-term pain.
Read the detailed description
This is a double-blind, randomized, pre- and post-test control group study to evaluate the effectiveness of adding dexmedetomidine as an adjuvant to continuous epidural analgesia for patients undergoing gynecologic laparotomy.
Postoperative pain following laparotomy can be severe and is associated with inflammation and a risk of developing chronic postsurgical pain (CPSP). While epidural analgesia is a standard method for pain management, this study investigates whether the addition of dexmedetomidine (an alpha-2 adrenergic agonist) provides superior analgesia and anti-inflammatory effects compared to local anesthetic alone.
Participants aged 30-55 with ASA physical status I-III will be randomized into two groups:
Group P1 (Intervention): Receives an epidural bolus and continuous infusion of bupivacaine 0.1% combined with dexmedetomidine 0.5 mcg/ml.
Group P2 (Control): Receives an epidural bolus and continuous infusion of bupivacaine 0.1% alone.
The epidural catheter will be inserted at the L1-L2 level prior to the induction of general anesthesia. Postoperative pain will be managed using a Patient-Controlled Epidural Analgesia (PCEA) pump with specific settings (3 ml/hr background infusion, 5 ml bolus demand, 30-minute lockout).
Key outcome measures include:
Acute Pain: Visual Analogue Scale (VAS) scores recorded at 6, 12, and 24 hours post-operation.
Analgesic Consumption: Total volume of bupivacaine used and total PCEA demands in 24 hours.
Inflammatory Response: Changes in Nuclear Factor Kappa B (NFκB) levels measured from blood samples taken pre-operatively and 24 hours post-operatively.
Chronic Pain: Incidence of chronic pain assessed 3 months post-operatively using the Brief Pain Inventory Short Form (BPI-SF).
Safety: Monitoring for adverse events such as hypotension and bradycardia.
- Being tested
- Dexmedetomidine & Bupivacaine., Bupivacain
- Keywords
- Dexmedetomidine, Bupivacaine, Epidural Analgesia, Gynecologic Laparotomy, NF-kappa B
- Medical subject headings
- Pain, Postoperative, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine & Bupivacaine.Drug
Epidural administration of Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation.
BupivacainDrug
Epidural administration of Bupivacaine 0.1% without adjuvant. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation.
| Study group | Role | What they receive |
|---|---|---|
| Group P1 (Dexmedetomidine Adjuvant) | Experimental | Participants receive epidural analgesia with Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation. Receives: Drug: Dexmedetomidine & Bupivacaine. |
| Group P2 (Control) | Active comparator | Participants receive epidural analgesia with Bupivacaine 0.1% alone (without adjuvant). This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation. Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (VAS)
Pain intensity is assessed using the Visual Analogue Scale (VAS). The VAS consists of a 100 mm straight line where the left end indicates "no pain" and the right end indicates "very severe pain" (0-100 mm). Participants mark the line to indicate their pain level. Higher scores indicate worse pain
Measured: 6, 12, and 24 hours post-operation
Secondary outcomes (5)
Total Bupivacaine Consumption
The total volume of Bupivacaine (in milliliters) consumed via the Patient-Controlled Epidural Analgesia (PCEA) pump during the postoperative period.
Measured: 24 hours post-operation.
Total PCEA Demands
The total number of times the participant pressed the PCEA button to request an analgesic bolus dose (total demand).
Measured: 24 hours post-operation.
Change in Nuclear Factor Kappa B (NFκB) Level
The difference in serum levels of the inflammatory biomarker Nuclear Factor Kappa B (NFκB). This is calculated as the value at 24 hours post-operation minus the pre-operative baseline value.
Measured: Baseline (Pre-operative) and 24 hours post-operation.
Incidence of Chronic Postsurgical Pain
The occurrence of chronic pain assessed using the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF measures pain severity (worst, least, average, now) and pain interference with daily activities. Scores range from 0 to 10, with higher scores indicating worse pain/interference .
Measured: 3 months post-operation.
Incidence of Bradycardia
The number of participants experiencing bradycardia, defined as a heart rate less than 50 beats per minute
Measured: Up to 24 hours post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start21 Aug 2025
- Primary completion15 Oct 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain, AcuteStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simson Samuel Soerodjotanojo, Udayana University
- Investigators
- Simson Samuel Soerodjotanojo, Principal investigator, Udayana UniversityI Gusti Ngurah Mahaalit Aribawa, Study director, Udayana UniversityI Made Agus Kresna Sucandra, Study director, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292324
- Sponsor's protocol ID
- 2171102008
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao Y, Chen Z, Huang Y, Sun S, Yang D. Comparison of dexmedetomidine and opioids as local anesthetic adjuvants in patient controlled epidural analgesia: a meta-analysis. Korean J Anesthesiol. 2024 Feb;77(1):139-155. doi: 10.4097/kja.22730. Epub 2023 May 2.
PubMed 37127531Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.
PubMed 27812971Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018.
PubMed 30464585
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Continuous Epidural With Dexmedetomidine Adjuvant Compared to Without Adjuvant in Gynecologic Laparotomy
- ClinicalTrials.gov ID
- NCT07292324
- Acronym / sponsor ID
- 2171102008
- Keywords
- Dexmedetomidine, Bupivacaine, Epidural Analgesia, Gynecologic Laparotomy, NF-kappa B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 18 Dec 2025 (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.
The goal of this clinical trial is to learn if adding a medication called dexmedetomidine to an epidural block works better than a standard epidural to control pain in women undergoing gynecologic laparotomy (abdominal surgery). The main questions it aims to answer are:
Does adding dexmedetomidine reduce pain scores and the need for extra pain medicine in the first 24 hours after surgery? Does it lower inflammation levels and reduce the risk of developing chronic pain 3 months later?
Participants will receive an epidural (pain medicine delivered through a small tube in the back) combined with general anesthesia for their surgery. Researchers will compare two groups:
One group will receive the standard epidural medicine (bupivacaine) mixed with dexmedetomidine.
The other group will receive the standard epidural medicine (bupivacaine) alone.
Researchers will measure the participants' pain levels, how much pain medicine they use, and blood markers for inflammation for 24 hours after surgery. They will also contact participants 3 months later to check for any long-term pain.
Detailed description
This is a double-blind, randomized, pre- and post-test control group study to evaluate the effectiveness of adding dexmedetomidine as an adjuvant to continuous epidural analgesia for patients undergoing gynecologic laparotomy.
Postoperative pain following laparotomy can be severe and is associated with inflammation and a risk of developing chronic postsurgical pain (CPSP). While epidural analgesia is a standard method for pain management, this study investigates whether the addition of dexmedetomidine (an alpha-2 adrenergic agonist) provides superior analgesia and anti-inflammatory effects compared to local anesthetic alone.
Participants aged 30-55 with ASA physical status I-III will be randomized into two groups:
Group P1 (Intervention): Receives an epidural bolus and continuous infusion of bupivacaine 0.1% combined with dexmedetomidine 0.5 mcg/ml.
Group P2 (Control): Receives an epidural bolus and continuous infusion of bupivacaine 0.1% alone.
The epidural catheter will be inserted at the L1-L2 level prior to the induction of general anesthesia. Postoperative pain will be managed using a Patient-Controlled Epidural Analgesia (PCEA) pump with specific settings (3 ml/hr background infusion, 5 ml bolus demand, 30-minute lockout).
Key outcome measures include:
Acute Pain: Visual Analogue Scale (VAS) scores recorded at 6, 12, and 24 hours post-operation.
Analgesic Consumption: Total volume of bupivacaine used and total PCEA demands in 24 hours.
Inflammatory Response: Changes in Nuclear Factor Kappa B (NFκB) levels measured from blood samples taken pre-operatively and 24 hours post-operatively.
Chronic Pain: Incidence of chronic pain assessed 3 months post-operatively using the Brief Pain Inventory Short Form (BPI-SF).
Safety: Monitoring for adverse events such as hypotension and bradycardia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P1 (Dexmedetomidine Adjuvant) | Experimental | Drug: Dexmedetomidine & Bupivacaine.Participants receive epidural analgesia with Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation. |
| Group P2 (Control) | Active comparator | Drug: BupivacainParticipants receive epidural analgesia with Bupivacaine 0.1% alone (without adjuvant). This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 30-55 years
- ASA physical status I-III
- Body Mass Index (BMI) 18 - 29.9 kg/m2
- Patients undergoing gynecologic laparotomy
Key exclusion criteria (9 listed)
- Contraindications for regional anesthesia
- Allergy or contraindication to dexmedetomidine
- Routine use of antidepressants or anticonvulsants
- Chronic opioid consumption (equivalent to >30 mg oral morphine per day for >1 month)
- History of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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 |
|---|---|---|
| Dexmedetomidine & Bupivacaine.Epidural administration of Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation. | Drug | Group P1 (Dexmedetomidine Adjuvant) |
| BupivacainEpidural administration of Bupivacaine 0.1% without adjuvant. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation. | Drug | Group P2 (Control) |
Primary outcome
Postoperative Pain Intensity (VAS)
Time frame: 6, 12, and 24 hours post-operation
Pain intensity is assessed using the Visual Analogue Scale (VAS). The VAS consists of a 100 mm straight line where the left end indicates "no pain" and the right end indicates "very severe pain" (0-100 mm). Participants mark the line to indicate their pain level. Higher scores indicate worse pain
5 secondary outcomes
Total Bupivacaine Consumption
Time frame: 24 hours post-operation.
Total PCEA Demands
Time frame: 24 hours post-operation.
Change in Nuclear Factor Kappa B (NFκB) Level
Time frame: Baseline (Pre-operative) and 24 hours post-operation.
Incidence of Chronic Postsurgical Pain
Time frame: 3 months post-operation.
Incidence of Bradycardia
Time frame: Up to 24 hours post-operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 37127531Gao Y, Chen Z, Huang Y, Sun S, Yang D. Comparison of dexmedetomidine and opioids as local anesthetic adjuvants in patient controlled epidural analgesia: a meta-analysis. Korean J Anesthesiol. 2024 Feb;77(1):139-155. doi: 10.4097/kja.22730. Epub 2023 May 2.
- Background: PubMed 27812971Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.
- Background: PubMed 30464585Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018.
- 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. This study is not recruiting at the moment.
Simson Samuel Soerodjotanojo principal investigator
Udayana University
I Gusti Ngurah Mahaalit Aribawa study director
Udayana University
I Made Agus Kresna Sucandra study director
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine & Bupivacaine. and Bupivacain in people with Post Operative Pain, Acute and Chronic Post Surgical Pain, run by Udayana University at 1 site in Indonesia.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Pain Intensity (VAS) (time frame: 6, 12, and 24 hours post-operation). 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 NCT07292324, which also lists 3 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 25 Mar 2026.