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A comparative study between injection buprenorphine vs injection dexmedetomidine with 0.375 percent ropivacaine in transversus abdominis plane block for postoperative pain relief in elective gynecological laparotomy patients.

A comparative study between injection buprenorphine hydrochloride versus injection dexmedetomidine with injection 0.375 percentage ropivacaine in transversus abdominus plane block for postoperative analgesia in patients undergoing elective gynecological exploratory laparotomy procedures: a randomized double-blind controlled study. - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/087998
Enrollment
60
Registered
2025-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D279- Benign neoplasm of unspecified ovary Health Condition 2: N800- Endometriosis of uterus Health Condition 3: D259- Leiomyoma of uterus, unspecified Health Condition 4: C569- Malignant neoplasm of unspecifiedovary Health Condition 5: C55- Malignant neoplasm of uterus, partunspecified

Interventions

Intervention1: Injection Buprenorphine Hydrochloride with Injection Ropivacaine.: Injection Buprenorphine hydrochloride 0.5 ml (150 microgram) with 20ml of 0.375% ropivacaine to be administered in bil

Sponsors

Dr Debashish Mondal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and ASA II, age between 20-60 years, female, BMI-24to 35 kg/m2, elective gynecological laparotomy surgery.

Exclusion criteria

Exclusion criteria: patient refusal, known hypersensitivity to local anesthetics, BMI greater than 35kg/m2, psychiatric or physical illness leading to debility or inability to cooperate, history of coagulopathy or bleeding diasthesis, opioid dependence, infection at injection site, NYHA greater than class2, chronic pain.

Design outcomes

Primary

MeasureTime frame
Comparison of duration of analgesia between the study drugs.Timepoint: Duration of analgesia will be calculated from the time of tranversus abdominis plane block administration with the study drug until there is requirement of administration of first rescue analgesic when the patient complains of pain. This time period from administration of study drug till the patient complains of pain will be the duration of analgesia provided by the study drug.

Secondary

MeasureTime frame
Comparison of quality of analgesia based on VAS (visual analog score), hemodynamic parameters, side-effects if any between the study groups.Timepoint: Quality of analgesia, hemodynamic parameters, side effects between the study groups will be assessed in postoperative period at 1st,2nd,4th,6th,8th,12th, 18th & 24th hours respectively.

Countries

India

Contacts

Public ContactDR DEBASHISH MONDAL

IPGMER and SSKM Hospital

dmondal2005@gmail.com8777854338

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026