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To compare spinal administration of morphine alone versus morphine with bupivacaine for pain relief during and after surgery in patients undergoing surgeries of liver or gall bladder.

To evaluate the effect of addition of Bupivacaine to intrathecal Morphine on intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia - a randomised controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078658
Enrollment
60
Registered
2024-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: intrathecal 0.25mg of morphine with 0.5% bupivacaine in patients undergoing hepatobiliary surgeries under general anaesthesia: 1 ml of 0.25mg morphine with 1 ml of 0.5% bupivacaine will

Sponsors

Bangalore Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients belonging to American Society of Anaesthesiologist class I-II, willing to give informed written consent, scheduled to undergo elective hepatobiliary surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: Patients not willing to give consent Patients undergoing emergency surgeries Patients having allergy to study drugs Patients having spinal anomalies or infection, coagulopathy, increased intracranial pressure Patients belonging to American Society of Anaesthesiologists class III-V Expected duration of surgery less than 90 min

Design outcomes

Primary

MeasureTime frame
To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesicsTimepoint: Time of requirement of first dose of Tramadol 1mg/kg body weight and total opioid requirement in 24 hrs

Secondary

MeasureTime frame
To assess post-operative analgesia using VAS scoreTimepoint: To assess the VAS score at 2,4,8,12 and 24 hours post-operatively;To assess hemodynamic parameters intra-operatively and post-operatively till 24 hoursTimepoint: To assess hemodynamic parameters intra-operatively and at 2,4,8,12,24 hours post-operatively;To compare the incidence of side effects such as hypotension, nausea, vomiting, pruritus, cough and sedationTimepoint: To assess the incidence of side effects and their severity based on four point ordinance scale upto 24 hours post-operatively

Countries

India

Contacts

Public ContactDr Sandhya K

Bangalore Medical College and Research Institute

sandyaraghu@gmail.com9972212417

Outcome results

None listed

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