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It is randomized controlled trial to know the efficacy of intrathecal morphine combined with 0.75% ropivacaine heavy for postoperative analgesia in laparoscopic cholecystectomy.

Efficacy of intrathecal morphine combined with 0.75% ropivacaine heavy for postoperative analgesia in laparoscopic cholecystectomy- a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045034
Enrollment
102
Registered
2022-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K819- Cholecystitis, unspecified

Interventions

Intervention1: Morphine (200 micrograms) with 0.75% Ropivacaine heavy diluted to a total volume of 2mL.: The drug will be given through intrathecal injection. Control Intervention1: 0.75% Ropivacaine

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: All adult male and female patients of age between 18-69 years and belonging to American society of Anaesthesiologist Physical Status I and II posted for elective laparoscopic cholecystectomy.

Exclusion criteria

Exclusion criteria: Patients of age more than 70years. Any allergy to local anaesthetic, opioids, morphine, NSAIDS or paracetamol. All contraindication to spinal anaesthesia. Use of abdominal drains for specific procedure related cause. Any surgery of duration more than 3 hours. Patient with body mass index of more than 30 Kg/m2 or any subject requiring ICU admission

Design outcomes

Primary

MeasureTime frame
To observe postoperative pain score using NRS scale. (it is a segmented numeric version of visual analog scale in which a patient selects a whole number (0-10) that reflects the intensity of his/her pain.) Time of first dose of rescue analgesia in hours (from T0 ââ?¬â?? time of arrival in post anaesthetic care unit). Inj. Tramadol 1.5mg/kg will be administered as rescue analgesic in 100ml normal saline over 15minutes, maximum dose not to exceed 100mg.Timepoint: Postoperatively for every 30min for first 2 hours and then after 4hours, 8 hours, 12hours and 24hours.

Secondary

MeasureTime frame
To observe postoperative pain score using NRS scale. Time of first dose of rescue analgesia in hours from T0 time of arrival in post anaesthetic care unit. Inj. Tramadol 1.5mg/kg will be administered as rescue analgesic in 100ml normal saline over 15minutes, maximum dose not to exceed 100mg. Total dose of rescue analgesia consumed in 24hours in mg To assess possible adverse effects such as pruritus, postoperative nausea and vomiting, and respiratory depression. To assess respiratory depression (SPO2 94% and respiratory rate12 breaths/minute) To assess anaesthesiologist satisfaction score based on parameters like able to take oral pain relief medications, able to move around, normal bowel bladder function using 5 point LIKERT SCORE. Residual motor block will be assessed using MODIFIED BROMAGE SCALE. Timepoint: Postoperatively for every 30min for first 2 hours and then after 4hours, 8 hours, 12hours and 24hours.

Countries

India

Contacts

Public ContactDr Amrita Panda

Kalinga Institute of Medical Sciences

amrita.panda@kims.ac.in9439862335

Outcome results

None listed

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