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Epidural morphine versus epidural local anaesthetic as pain killer after abdominal gastrointestinal cancer surgery

MOrphine-bupivacaine intermittent bolus versus Ropivacaine-Fentanyl INfusion through epidural route after gastrointestinal oncosurgery: a randomized clinical trial - MORFIN

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030076
Enrollment
86
Registered
2020-12-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: - Health Condition 2: C184- Malignant neoplasm of transverse colon

Interventions

Intervention1: Epidural Morphine- Bupivacaine intermittent Bolus: Epidural analgesia will be provided by Morphine 0.05 mg/kg diluted to 10 ml with Bupivacaine 0.1% solution [3 mg Morphine (1 ml) + 2ml

Sponsors

Tata Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who will undergo elective GI oncosurgery 2. American Society of Anaesthesiology (ASA-PS) score of 1 to 3

Exclusion criteria

Exclusion criteria: 1.Hepatobiliary and pancreatic surgery 2.Thoracic surgery 3.Patients with life threatening arrhythmias 4.Patients with left ventricular ejection fraction (LVEF) 5.Acute myocardial infarction (within 30 days) 6.Acute pulmonary oedema (within 7 days) 7.Chronic obstructive pulmonary disease with a forced expiratory volume (FEV1) in the first second of expiration of less than 50% 8.Emergency surgery 9.Coagulopathy (platelet x2 control, INR >1.5) 10.Significant liver dysfunction (liver enzymes >x3 times normal) 11.Significant renal dysfunction (creatinine >x2 times normal) 12.Psychiatric disorders 13.Sepsis before surgery. 14.Patients who have known hypersensitivity to any of the drugs used during the procedure 15.Patients who are not willing to sign the informed consent form 16.History of any significant condition which the investigator feels would interfere with study evaluations and study participation 17.Patients who are on transdermal opioids or long acting analgesics 18.Patients who have previously participated in this study and to undergo a second surgery

Design outcomes

Primary

MeasureTime frame
Intravenous fentanyl requirement as rescue analgesiaTimepoint: In 1st 24 hrs Post surgery

Secondary

MeasureTime frame
Length of hospital stayTimepoint: Length of hospital stay from the day of surgery to fitness to discharge will be noted.;Postoperative fluid administrationTimepoint: Hourly fluid intake and urine output will be measured during intraoperative and postoperative period;Postoperative pain scoreTimepoint: Pain score of the patient on rest and during spirometry in visual analog scale will be asked after shifting the patient to PACU and 1,6, 12, 24 hrs in 1st postoperative day and after that two times every day till POD 5;Requirement of vasopressorsTimepoint: If there is hemodynamic compromise [hypotension (SBP 90mm of Hg), urine output 0.5ml/kg/hr] intravenous fluid bolus with 5ml/kg will be infused. If hypotension persists even after fluid bolus, vasopressors will be given as per institutional protocol. Maximum Noradrenalin dose required to maintain normal haemodynamics will be noted during intraoperative period and every postoperative day.;Time to enteric resumptionTimepoint: Postoperative day when patient tolerated 500 ml enteric liquid will be documented.

Countries

India

Contacts

Public ContactRudranil Nandi

Tata Medical Center, Kolkata

drrudranilnandi@gmail.com9564713195

Outcome results

None listed

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