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Comparison of different doses of analgesic injected in the spine for pain relief after surgery.

Comparative evaluation of different doses of intrathecal morphine in reducing the requirement of postoperative epidural analgesia in patients undergoing major abdominal surgery: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068402
Enrollment
90
Registered
2024-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Group A: Receiving only epidural analgesia with 10 mL of 0.20% Ropivacaine.: Only epidural analgesia with 10 mL of 0.20% Ropivacaine. Control Intervention1: Group B: Receiving Intrathec

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients 18 years or older, both male and female, American Society of Anaesthesiology (ASA) grade I and II, undergoing major abdominal surgery will be considered for this study.

Exclusion criteria

Exclusion criteria: Patients who refuse to consent for the study. Patients with ASA grade III or higher. Patients in sepsis or septic shock. Patients with respiratory diseases like chronic obstructive pulmonary disease, asthma, restrictive lung disease etc. or cardiac diseases like ischemic heart disease, arrythmias etc. Patients with spine deformities. Patients with liver disease or coagulopathy. Opioid dependent patients. Those with a history of chronic pain syndromes or chronic opioid use (more than 60 mg oral morphine equivalent daily). Any patient requiring post-operative ventilatory support in view of surgical reasons, hemodynamic instability, acid base imbalance or hypothermia.

Design outcomes

Primary

MeasureTime frame
The total requirement of epidural infusion will be calculated over first 24 hours in all 3 groups.Timepoint: 24 hours after the patient gets extubated.

Secondary

MeasureTime frame
Heart rate, Mean Arterial Pressure, SPO2, EtCO2, Bispectral index, Temperature, Volume of 0.2% Epidural ropivacaine used in mL.Timepoint: Before Induction, after induction, at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours and after extubation. ;Non-invasive blood pressure, heart rate and SpO2 are measured just before epidural insertion, just after epidural insertion, 5 minutes, 10minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after epidural insertion.Timepoint: Just before epidural insertion, just after epidural insertion, 5 minutes, 10minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after epidural insertion.;Perioperative complications like Richmond Agitation Sedation Scale (RASS), Respiratory depression, Reintubation, Nausea, Vomiting and pruritis. Timepoint: Measured at the end of surgery till 1 hour after surgery.;Heart rate, mean arterial pressure, SPO2 and Numerical Rating ScaleTimepoint: Measured at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours. ;Total epidural dose used in first 24 hours and QoR15 at 24 hours is measured.Timepoint: Measured at 24 hours.;QoR15 is measured at the time of discharge.Timepoint: Measured at the time of discharge.

Countries

India

Contacts

Public ContactDr Deepak Singla

AIIMS Rishikesh

deepak10.4u@gmail.com9068504999

Outcome results

None listed

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