| CTRI Number |
CTRI/2025/02/080666 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare spinal administration of drug morphine versus fentanyl for pain relief during and after surgery in patients undergoing surgeries of liver or gall bladder. |
|
Scientific Title of Study
|
To compare the efficacy and safety of intrathecal Morphine and Fentanyl on intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia |
| 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 Sandhya K |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute Super Speciality Hospital, Fort, Krishna Rajendra road, New Tharaguppettu, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9972212417 |
| Fax |
|
| Email |
sandyaraghu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Malavika P Nair |
| Designation |
Post graduate Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra road, New Tharaguppettu, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9746900270 |
| Fax |
|
| Email |
pnairmalavika@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Malavika P Nair |
| Designation |
Post graduate Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra road, New Tharaguppettu, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9746900270 |
| Fax |
|
| Email |
pnairmalavika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, Fort, Krishna Rajendra road, New Tharaguppett, Bangalore, Karnataka 560002, India |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Fort, Krishna Rajendra road, New Tharaguppett, Bangalore, Karnataka 560002 |
| Type of Sponsor |
Government medical college |
|
|
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 Sandhya K |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra road, New Tharaguppett, Bangalore, Karnataka 560002 Bangalore KARNATAKA |
9972212417
sandyaraghu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K70-K77||Diseases of liver, (2) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal 0.025mg of fentanyl in patients undergoing hepatobiliary surgeries under general anaesthesia |
1 ml of 0.025mg fentanyl diluted to 2 ml will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia and patient will be followed up till 24 hours for assessing post-operative pain, requirement of rescue analgesics and associated side effects |
| Intervention |
Intrathecal 0.25mg of morphine in patients undergoing hepatobiliary surgeries under general anaesthesia |
1 ml of 0.25mg morphine diluted to 2 ml will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia and patient will be followed up till 24 hours for assessing post-operative pain, requirement of rescue analgesics and associated side effects |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients belonging to American Society of Anaesthesiologist class I-II, willing to give informed written consent, scheduled to
undergo elective hepatobiliary surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent
Patients undergoing emergency surgeries
Patients having allergy to study drugs
Patients having spinal anomalies or infection, coagulopathy, increased intracranial pressure
Patients belonging to American Society of Anaesthesiologists class III-V
Expected duration of surgery less than 90 min
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesics
|
To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesics at 2nd, 4th, 8th, 12th and 24th hour following surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess post-operative analgesia using VAS score |
To assess the VAS score at 2,4,8,12 and 24 hours post-operatively |
| To compare the incidence of side effects such as hypotension, nausea, vomiting, pruritus, cough, respiratory depression and sedation |
To assess the incidence of side effects and their
severity based on four point ordinance scale upto 24 hours post-operatively
|
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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="0" Months="4" 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
|
Hepatobiliary surgeries are more frequently performed nowadays due to a rising incidence of hepatobiliary diseases. Effectively administered analgesia enables greater patient satisfaction by minimising acute postoperative pain, alleviates the acute physiological stress response to surgery, and facilitates enhanced recovery outcomes including early mobilisation and return to normal activity, reduced length of hospital stay, and reduced cardiac, respiratory and gastrointestinal postoperative complications leading to improved long-term patient survival rates. Thoracic epidural analgesia is considered the gold standard analgesic modality for patients undergoing hepatobiliary surgeries as it provides adequate analgesia to support mobilization, with significant reduction in pulmonary, cardiovascular and thromboembolic morbidity in early post-operative period and reduced requirement of additional opioid analgesia. However , there exists high rates of epidural failure and complications especially since it is an invasive, high-cost, labour-intensive technique. Also , there is increased risk of epidural hematoma formation due to coagulation abnormalities after hepatobiliary surgeries, even in patients with normal preoperative coagulation profile. Furthermore, the epidural catheter should be removed in a timely manner to minimize complications due to post-operative coagulation disturbances. In view of the concerns raised with epidural analgesia in hepatobiliary surgeries, intrathecal anaesthesia has emerged as a promising simpler and quicker alternative technique, yielding better patient outcomes with a lower rate of technical failure. Fentanyl is a phenyl piperidine derivative, synthetic opioid agonist which is more potent, more lipid soluble with faster onset of action and relatively shorter duration of action. Morphine is a hydrophilic phenanthrene derivative with comparatively slower onset of action and a significantly longer duration of action. However, it has the potential to cause adverse effects, especially delayed respiratory depression and hence requires more vigilant protocol. Hence this study aims at comparing the efficacy and safety of intrathecal morphine and fentanyl in hepatobiliary surgeries under GA , in terms of intraoperative and post operative analgesia, requirement of rescue analgesics and potential side effects. |