Comparing Pain Relief: Single Dose Spinal Morphine vs IV Fentanyl Pump in Robotic Abdominal and Pelvic Surgery

Analgesic Efficacy of a Single Dose of Intrathecal Morphine Versus Intravenous Patient Controlled Analgesia with Fentanyl in Robotic-Assisted Laparoscopic Major Abdominal and Pelvic Surgeries: A Prospective Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096398

Enrollment

Registered

2025-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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 Health Condition 2: R52- Pain, unspecified

Interventions

Intervention1: Single Dose of Intrathecal Morphine GROUP M: Patients allocated to Group M will receive intrathecal morphine at a dose of two micrograms per kilogram of body weight, with a maximum dose

Eligibility

Inclusion criteria

Inclusion criteria: A. Patients undergoing robotic assisted laparoscopic major abdominal and pelvic surgeries B.American Society of Anesthesiologists (ASA) physical status I to III

Exclusion criteria

Exclusion criteria: Patients who are allergic to morphine Patients with local or systemic infections Patients with deranged coagulation profile Patients with elevated intracranial pressures Blurring of vision,Headache, Ophthalmic changes Patients suffering from chronic pain with baseline opioid use Laparoscopic surgeries converted into open surgeries Re-exploration surgeries Pregnant or lactating women Morbid obese patients BMI more than 30 or history of sleep apnea

Design outcomes

Primary

Measure	Time frame
To determine the cumulative dose of opioids (by using Morphine equivalents) following single dose of Intrathecal morphine vs Intravenous patient controlled analgesia (IV-PCA) Fentanyl over 24 hours among patients undergoing robotic assisted laparoscopic major abdominal and pelvic surgeries.Timepoint: Patient shall be assessed postoperatively over 24 hours	—

Secondary

Measure	Time frame
1. Comparison of postoperative pain in the first 24 hours(0,3,6,12,24hrs) using NRS score at rest and movement. 2. To Determine the rescue doses of opioid and non opioid analgesic received in both groups in the first 24 hours. 3. To observe the incidence of adverse side effects associated with intrathecal morphine including respiratory depression, pruritus, post dural puncture headache, nausea and vomiting. 4. To Determine the impact on post operative recovery using parameters such as return of bowel function, mobilisation, length of hospital stay. Timepoint: Patients Shall be assessed for postoperative pain in the first 24 hours at 0,3,6,12,24hrs	—

Measure

Time frame

1. Comparison of postoperative pain in the first 24 hours(0,3,6,12,24hrs) using NRS score at rest and movement. 2. To Determine the rescue doses of opioid and non opioid analgesic received in both groups in the first 24 hours. 3. To observe the incidence of adverse side effects associated with intrathecal morphine including respiratory depression, pruritus, post dural puncture headache, nausea and vomiting. 4. To Determine the impact on post operative recovery using parameters such as return of bowel function, mobilisation, length of hospital stay. Timepoint: Patients Shall be assessed for postoperative pain in the first 24 hours at 0,3,6,12,24hrs

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Countries

India

Contacts

Public ContactDr Bindu George

St Johns Medical College

bindu575@gmail.com9342552324

Outcome results

None listed

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