Pain relief after gallbladder surgery: A study comparing two doses of a medicine dexmedetomidine mixed with ropivacaine sprayed inside the abdomen in patients undergoing laparoscopic cholecystectomy

Comparative Study of Intraperitoneal Instillation of Ropivacaine with Two Different Doses of Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094278

Enrollment

Registered

2025-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine: Group RD1: Intraperitoneal spraying of 0.2% Ropivacaine 40ml with 0.5 ?g/kg Dexmedetomidine Intervention2: Dexmedetomidine: Group RD2: Intraperitoneal spraying of 0.2%

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years undergoing elective laparoscopic cholecystectomy ASA physical status I,II.

Exclusion criteria

Exclusion criteria: ASA physical status III or IV. Patients with contraindications to ropivacaine or dexmedetomidine. Patients with chronic pain conditions or on chronic opioid therapy. Patients who are unwilling to participate in the study.

Design outcomes

Primary

Measure	Time frame
To evaluate the duration of analgesia following intraperitoneal administration of ropivacaine with two different doses of dexmedetomidine.Timepoint: Continuous monitoring until first rescue analgesic ? records exact time (hours and minutes) from end of surgery to first rescue dose. Pain scores (NPRS) to detect the need for rescue will be recorded at: 0 h (on arrival to PACU), 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 12 h, 18 h and 24 h. If no rescue analgesic is required within 24 h, duration is censored at 24 h.	—

Measure

Time frame

To evaluate the duration of analgesia following intraperitoneal administration of ropivacaine with two different doses of dexmedetomidine.Timepoint: Continuous monitoring until first rescue analgesic ? records exact time (hours and minutes) from end of surgery to first rescue dose. Pain scores (NPRS) to detect the need for rescue will be recorded at: 0 h (on arrival to PACU), 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 12 h, 18 h and 24 h. If no rescue analgesic is required within 24 h, duration is censored at 24 h.

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Secondary

Measure	Time frame
To evaluate the total analgesic consumption in the first 24 hours postoperatively. To evaluate sedation scores at various time intervals. To evaluate the incidence of shoulder pain in the first 24 hours. To monitor the postoperative bowel movementsTimepoint: Total analgesic consumption recorded cumulatively at 24 hours Ramsay sedation score at 0,1,2,3,4,5,6,12,18,24 hours Shoulder pain assessed at 1,6,24 hours (present/absent, onset noted) Bowel movements monitored up to 24 hours (time of first flatus recorded)	—

Measure

Time frame

To evaluate the total analgesic consumption in the first 24 hours postoperatively. To evaluate sedation scores at various time intervals. To evaluate the incidence of shoulder pain in the first 24 hours. To monitor the postoperative bowel movementsTimepoint: Total analgesic consumption recorded cumulatively at 24 hours Ramsay sedation score at 0,1,2,3,4,5,6,12,18,24 hours Shoulder pain assessed at 1,6,24 hours (present/absent, onset noted) Bowel movements monitored up to 24 hours (time of first flatus recorded)

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Countries

India

Contacts

Public ContactManeesh V S

Naruvi Hospitals

sarandoc2000@gmail.com9629957683

Outcome results

None listed

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