FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096398 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Pain Relief: Single Dose Spinal Morphine vs IV Fentanyl Pump in Robotic Abdominal and Pelvic Surgery 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nehal Joy 
Designation  Post Graduate Student 
Affiliation  St Johns Medical College 
Address  Department OF Anesthesiology St. Johns Medical College and Hospital Sarjapur Road, Bangalore - 560034, Karnataka,

Bangalore
KARNATAKA
560034
India 
Phone  7899005201  
Fax    
Email  nehal.joy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu George 
Designation  Professor 
Affiliation  St Johns Medical College 
Address  Department OF Anesthesiology St. Johns Medical College and Hospital Sarjapur Road, Bangalore - 560034,

Bangalore
KARNATAKA
560034
India 
Phone  9342552324  
Fax    
Email  bindu575@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bindu George 
Designation  Professor 
Affiliation  St Johns Medical College 
Address  Department OF Anesthesiology St. Johns Medical College and Hospital Sarjapur Road, Bangalore - 560034,

Bangalore
KARNATAKA
560034
India 
Phone  9342552324  
Fax    
Email  bindu575@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia and Critical Care, St.Johns Medical College 
 
Primary Sponsor  
Name  Department of Anesthesia and Critical Care, St.Johns Medical College 
Address  Room no.7, OT Complex,2nd Floor, St. Johns Medical College and Hospital, Sarjapur-Marthahalli Rd, Beside Bank Of Baroda, John Nagar, Koramangala Bangalore 560034 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nehal Joy  St.Johns Medical College  Department of Anesthesia and Critical Care, Room no.7, OT Complex,2nd Floor, St. Johns Medical College and Hospital, Sarjapur-Marthahalli Rd, Beside Bank Of Baroda, John Nagar, Koramangala Bangalore 560034
Bangalore
KARNATAKA 
7899005201

nehal.joy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, St. Johns Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  s Intravenous Patient-Controlled Analgesia with Fentanyl GROUP C  Group C will be initiated on intravenous patient-controlled analgesia with a continuous infusion of twenty micrograms, patient-controlled boluses of twenty micrograms upon request, and a twenty-minute lockout period Post operatively in the Post Anaesthesia Care Unit and Shall be Continued post operatively for 24hrs 
Intervention  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 of 200 micrograms. Patients will be positioned in a sitting position, and under strict aseptic precautions, the lumbar region will be prepared using chlorhexidine. The L3-L4 or L4-L5 intervertebral space will be identified by palpation. Local anesthesia with two percent lignocaine will be administered at the puncture site, followed by the insertion of a 25-gauge Quincke needle. For Group M, preservative-free morphine at 15 milligrams per milliliter is initially diluted with sterile saline to 1.5 milligrams per milliliter using a ten-milliliter syringe. One milliliter of this solution is further diluted to 150 micrograms per milliliter in another ten-milliliter syringe. The first syringe is removed to prevent confusion. The required dose of two micrograms per kilogram, with a maximum of 200 micrograms, is extracted and further diluted to two milliliters with saline for administration. followed by General Anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  A. Patients undergoing robotic assisted laparoscopic major abdominal and pelvic surgeries

B.American Society of Anesthesiologists (ASA) physical status I to III
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  Patient shall be assessed postoperatively over 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
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.
 
Patients Shall be assessed for postoperative pain in the first 24 hours at 0,3,6,12,24hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   03/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After obtaining approval from the Institutional Ethics Committee, patients meeting the inclusion criteria and providing informed consent for participation will be enrolled in the study. Randomization will be done using sealed opaque envelopes, maintaining a one-to-one ratio for equal distribution across the study. The envelopes will be sealed and stored until a patient arrives in the pre-anesthetic holding area. At that point, the attending anesthesiologist will open the envelope and proceed according to the group assigned to the patient. The attending anesthesiologist will not be involved in data collection.

Upon arrival in the operating room, patients will be connected to American Society of Anesthesiologists standard monitors such as a non-invasive blood pressure cuff, a three-lead electrocardiogram, and a pulse oximeter. Baseline vital readings will be recorded before proceeding with anesthesia. An intravenous line using an 18-gauge cannula in both upper limbs with 100-centimeter extension lines and a three-way stopcock will be inserted, and Ringer’s lactate will be started. Following this, ondansetron four milligrams intravenously will be administered.

Patients allocated to Group M will receive intrathecal morphine at a dose of two micrograms per kilogram of body weight, with a maximum dose of 200 micrograms. Patients will be positioned in a sitting position, and under strict aseptic precautions, the lumbar region will be prepared using chlorhexidine. The L3-L4 or L4-L5 intervertebral space will be identified by palpation. Local anesthesia with two percent lignocaine will be administered at the puncture site, followed by the insertion of a 25-gauge Quincke needle.

For Group M, preservative-free morphine at 15 milligrams per milliliter is initially diluted with sterile saline to 1.5 milligrams per milliliter using a ten-milliliter syringe. One milliliter of this solution is further diluted to 150 micrograms per milliliter in another ten-milliliter syringe. The first syringe is removed to prevent confusion. The required dose of two micrograms per kilogram, with a maximum of 200 micrograms, is extracted and further diluted to two milliliters with saline for administration.

After the procedure, patients will be positioned appropriately for the induction of general anesthesia. Following adequate preoxygenation, all patients will receive premedication with midazolam 0.03 milligrams per kilogram, glycopyrrolate 0.01 milligrams per kilogram, and ondansetron 0.15 milligrams per kilogram. Induction of general anesthesia will be achieved using fentanyl two micrograms per kilogram and a titrated dose of propofol two milligrams per kilogram until the loss of verbal contact. Neuromuscular blockade will be achieved using atracurium at a dose of 0.5 milligrams per kilogram administered after induction and maintained intraoperatively with a continuous infusion of atracurium at 0.5 milligrams per kilogram per hour via an infusion pump. Intraoperative monitoring will include standard parameters along with a skin temperature probe to monitor core temperature. Anesthesia will be maintained using isoflurane, titrated to achieve a minimum alveolar concentration of 1.1 to 1.2, delivered in a fifty percent oxygen-in-air mixture. All patients will receive intravenous dexamethasone four milligrams following induction.

Patients allocated to Group C, following the induction of general anesthesia, will have neuromuscular blockade facilitated with atracurium at a dose of 0.5 milligrams per kilogram, and it will be maintained intraoperatively with a continuous infusion at 0.5 milligrams per kilogram per hour. Patients allocated to Group C will then receive a continuous infusion of fentanyl at 0.5 micrograms per kilogram per hour via an infusion pump throughout the intraoperative period to ensure consistent analgesia.

After induction, the surgical team will install and operate the Da Vinci Surgical System following the manufacturer’s guidelines. Continuous intraoperative monitoring will be conducted to ensure patient stability. Intraoperative vital recordings will be done at baseline, carbon dioxide insufflation, retrieval of the specimen, and the end of surgery. Intraoperative monitoring includes heart rate, blood pressure, oxygen saturation, end-tidal carbon dioxide, and temperature. The surgical duration, episodes of hypotension defined as mean arterial pressure below 65 millimeters of mercury, use of rescue ephedrine dose, fentanyl dose, hourly fluid intake, and total blood loss will be recorded.

Rescue opioids will be administered to Group M if the mean arterial pressure increases by more than twenty percent from baseline. In such cases, patients in Group M will receive intravenous fentanyl boluses at a dose of 0.5 micrograms per kilogram as needed.

Before the introduction of the robotic arm, port sites will be infiltrated with 0.25 percent bupivacaine. Prior to wound closure, all patients will receive paracetamol one gram intravenously and local infiltration of 0.25 percent bupivacaine at the port site incisions. At the conclusion of the procedure, neuromuscular blockade will be reversed using neostigmine 0.05 milligrams per kilogram and glycopyrrolate 0.01 milligrams per kilogram. Extubation will be performed once the patient is fully awake and meets all extubation criteria. Any failure of extubation will be documented and managed according to institutional protocol.

Postoperatively, patients will be transferred to the post-anesthesia care unit where the Numeric Rating Scale score will be recorded at rest and during movement. Group C will be initiated on intravenous patient-controlled analgesia with a continuous infusion of twenty micrograms, patient-controlled boluses of twenty micrograms upon request, and a twenty-minute lockout period.

During the first twenty-four hours postoperatively, continuous monitoring will include electrocardiogram, oxygen saturation, level of consciousness, and respiratory rate and depth to ensure early detection of complications. Cumulative opioid consumption will be assessed at twelve and twenty-four hours postoperatively. Postoperative assessments will be conducted at zero hours in the post-anesthesia care unit and subsequently at three, six, twelve, and twenty-four hours. Rescue opioid usage will be monitored throughout the first twenty-four hours.

As part of a multimodal pain management strategy, all patients will receive intravenous paracetamol one gram every eight hours. Breakthrough pain defined as a Numeric Rating Scale greater than four will be managed with either fentanyl 0.5 micrograms per kilogram intravenously or tramadol fifty milligrams intravenously, at the discretion of the physician. Nonsteroidal anti-inflammatory drugs will be avoided.

Pain severity will be assessed using the eleven-point Numeric Rating Scale. A structured proforma will be used to evaluate potential complications related to intrathecal morphine and spinal anesthesia, including respiratory rate less than eight, respiratory depth, oxygen saturation below ninety-two percent, level of consciousness, post-dural puncture headache, pruritus, nausea, and vomiting. All data will be systematically recorded and compiled into a spreadsheet for statistical analysis.

 
Close