| CTRI Number |
CTRI/2024/06/068402 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of different doses of analgesic injected in the spine for pain relief after surgery. |
|
Scientific Title of Study
|
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 |
| 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 Shreya Singh |
| Designation |
Post graduate student |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No 016133 Department of Anaesthesiology All India Institue of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand
Dehradun UTTARANCHAL 249204 India |
| Phone |
8439165797 |
| Fax |
|
| Email |
shreyakomail98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Singla |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No 016133 Department of Anaesthesiology All India Institue of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand
Dehradun UTTARANCHAL 249204 India |
| Phone |
9068504999 |
| Fax |
|
| Email |
deepak10.4u@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Singla |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No 016133 Department of Anaesthesiology All India Institue of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand
Dehradun UTTARANCHAL 249204 India |
| Phone |
9068504999 |
| Fax |
|
| Email |
deepak10.4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH |
| Address |
Veerbhadra Road Near Barrage Sturida Colony Pahsulok Rishikesh Uttarakhand 249203 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreya Singh |
AIIMS Rishikesh |
Room No 016133 Department of Anaesthesiology All India Institue of Medical Sciences Rishikesh Virbhadra Road Rishikesh Uttarakhand Dehradun UTTARANCHAL |
8439165797
shreyakomail98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Receiving only epidural analgesia with 10 mL of 0.20% Ropivacaine. |
Only epidural analgesia with 10 mL of 0.20% Ropivacaine. |
| Comparator Agent |
Group B: Receiving Intrathecal analgesia with 500mcg of Morphine + Epidural analgesia with 10mL of 0.20% Ropivacaine.
|
Intrathecal analgesia with 500mcg of Morphine + Epidural analgesia with 10mL of 0.20% Ropivacaine. |
| Comparator Agent |
Group C: Receiving Intrathecal analgesia with 1mg of Morphine + Epidural analgesia with 10mL of 0.20% Ropivacaine. |
Intrathecal analgesia with 1mg of Morphine + Epidural analgesia with 10mL of 0.20% Ropivacaine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The total requirement of epidural infusion will be calculated over first 24 hours in all 3 groups. |
24 hours after the patient gets extubated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
Just before epidural insertion, just after epidural insertion, 5 minutes, 10minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after epidural insertion. |
Heart rate, Mean Arterial Pressure, SPO2, EtCO2, Bispectral index, Temperature,
Volume of 0.2% Epidural ropivacaine used in mL. |
Before Induction, after induction, at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours and after extubation.
|
Perioperative complications like Richmond Agitation Sedation Scale (RASS), Respiratory depression, Reintubation, Nausea, Vomiting and pruritis.
|
Measured at the end of surgery till 1 hour after surgery. |
| Heart rate, mean arterial pressure, SPO2 and Numerical Rating Scale |
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. |
Measured at 24 hours. |
| QoR15 is measured at the time of discharge. |
Measured at the time of discharge. |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Written informed consent will be obtained from all patients before considering them for this study. All patients meeting the inclusion criteria who give the consent will be included in the study. After establishing intravenous (IV) access and standard hemodynamic monitoring (i.e., ECG, non-invasive blood pressure, and Spo2) will be applied to all patients. Patients would be randomized into 3 groups (based on the regional analgesic technique used before the start of surgery) for the study based on computer generated randomization sequence: Group A: Receiving only epidural analgesia with 10 mL of 0.20% Ropivacaine. Group B: Receiving Intrathecal analgesia with 5 mcg/kg up to a maximum dose of 500 mcg of Morphine + Epidural analgesia with 10mL of 0.20% Ropivacaine. Group C: Receiving Intrathecal analgesia with 10 mcg/kg up to a maximum dose of 1mg of Morphine + Epidural analgesia with 10mL of 0.20% Ropivacaine. Under all aseptic precautions intrathecal and epidural analgesia will be administered to all patients depending upon their group allocation, in the sitting position using a 25- or 27-gauge Quincke needle and 18 G Tuohy needle and epidural catheter at the T8-T9 or T9-T10 interspace. Anaesthesia will be induced with injection fentanyl (2 mcg / kg), propofol (1.5 -2 mg/ kg), followed by vecuronium (0.1 mg/ kg) to facilitate endotracheal intubation. End tidal CO2, temperature, BIS and urine output monitoring will be done intraoperatively. Further monitoring i.e., invasive arterial blood pressure and central venous pressure, will be based on the discretion of anaesthesiologist managing the patient. Blood pressure (BP) and Heart rate (HR) are to be measured every minute for 5 minutes after propofol administration. After preintubation measurements for 5 minutes, the trachea will be intubated with appropriate endotracheal tube size. The infusion rate of crystalloid to be fixed at approximately 10ml/hour per actual body weight during the study period. Maintenance of anaesthesia will be done with O2: Air in ratio of 40:60, intermittent vecuronium, fentanyl and sevoflurane (MAC 0.8-1). Ventilation will be controlled to maintain ETCO2 between 31-40 mmHg. The dose and frequency of administration of epidural analgesia would be recorded intraoperatively. Patients would be monitored intra-operatively for any hemodynamic instability. Systolic blood pressure less than or equal to 80 mmHg or greater than 30% decrease from baseline before intubation will be defined as significant hypotension. Mephentermine (6mg) will be given if systolic blood pressure (SBP) falls to 80mmHg or less. At the end of surgery, the muscle relaxation will be reversed with injection neostigmine (0.04- 0 08 mg/kg) and glycopyrrolate (0.005-0 01 mg/kg) and patient extubated. Postoperatively, all the patients will be monitored for 24 hours post operatively either in ICU or surgical HDU. (to monitor for any side effects of intrathecal morphine) In the post-operative period, the patients will be provided analgesia by patient-controlled analgesia (PCA) pump: 1). Continuous epidural infusion of 0.25% ropivacaine + 4.0 mcg/ml Fentanyl @ 2mL/hour. 2). Bolus dose of 2mL of Fentanyl 4.0 mcg/ml + 0.25 % Ropivacaine with a lock out interval of 30 minutes. The post-operative vitals i.e., heart rate, blood pressure, spo2 and pain score (based on NRS scale) will be recorded in all patients immediately after the surgery, every 30 minutes till first 2 hours, one hourly from 2 to 6 hours, 2 hourly till 12 hours, 4 hourly till 24 hours. The total requirement of epidural infusion will be calculated over first 24 hours in all 3 groups. Also, the QoR-15 score will be assessed for post-operative recovery in all the three groups at 24 hours and at the time of discharge. Mean length of hospital-stay will be compared in all three groups. Any incidence of excessive sedation (-3 on Richmond agitation and sedation scale) respiratory depression (defined as fall in SpO2 below 90%, rise in PCO2 to more than 50 mm of Hg or by more than 20 mm of Hg from baseline value (immediate extubation), or higher or respiratory rate of <10/minute), nausea, vomiting, pruritis will be noted. In case of respiratory depression, supplemental oxygen with oxygen mask will be given to the patient. If patient still doesn’t respond endotracheal intubation with elective ventilation will be done and the incidence of same will be noted. |