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Comparison of Intraperitoneal administration (giving drug into the abdominal cavity) of Ropivacaine (local anaesthetic) with Dexmedetomidine (sedative) Versus Ropivacaine with Ketamine (sedative) for Post Operative Pain Relief Following Laparoscopic Cholecystectomy

A Randomized Controlled Study for Evaluation of the Efficacy of Intraperitoneal Instillation of Ropivacaine with Dexmedetomidine Versus Ropivacaine with Ketamine for Post Operative Pain Relief Following Laparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022129
Enrollment
60
Registered
2019-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K80- Cholelithiasis

Interventions

Intervention1: Intraperitoneal instillation of local anaesthetic agent alone or with adjuvant: After the removal of the gall bladder a total of 40 ml study drug solution will be instilled intaperitone

Sponsors

UCMS and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1.Patients with cardiovascular, pulmonary, psychological or neurological diseases 2.Patients who are known to be epileptic 3.Patients who have an increase in intracranial tension 4.Patients with known allergies to the study drugs 5.Patients with abnormalities like heart block, left bundle branch block 6.Patients in whom the procedure will be converted to open cholecystectomy 7.Obese patients (BMI more than or equal to 30) 8.Patients in whom subhepatic drain is inserted after the removal of gall bladder.

Design outcomes

Secondary

MeasureTime frame
Any adverse effectsTimepoint: first 24 hours ;Hemodynamic parameters at the time of extubationTimepoint: Intraoperative, Immediate postoperative, 5 mins, 10 mins, 15 mins, 30 mins, 1h, 1 h 30 mins, 2h, 3h, 4h, 5h, 6h, 7h, 8h ;Post-operative pain using Numeric Rating Scale (NRS)- Static and Dynamic.Timepoint: 30 min, 1 h, 2h, 3h, 4 h, 6h, 8 h, 12 h, 18 h and 24 h postoperatively;Time to extubation. Timepoint: Once, at the time of tracheal extubation;To assess the quality of post operative pain using Revised American Pain Society Patient Outcome Questionnaire.Timepoint: After 24 hours;Total dose of rescue analgesia requiredTimepoint: First 24 hours

Primary

MeasureTime frame
Time to demand of first dose of rescue analgesia in the three groupsTimepoint: Once, during first 24 hours, when patient complains of pain and NRS is more than or equal to 4

Countries

India

Contacts

Public ContactDr Steffi Dua

UCMS and GTBH

rudoc@rediffmail.com9560678023

Outcome results

None listed

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