| CTRI Number |
CTRI/2024/12/078658 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| 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 morphine alone versus morphine with bupivacaine for pain relief during and after surgery in patients undergoing surgeries of liver or gall bladder. |
|
Scientific Title of Study
|
To evaluate the effect of addition of Bupivacaine to intrathecal Morphine on intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia - a randomised 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 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 Tharaguppett,
Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9746900270 |
| Fax |
|
| Email |
pnairmalavika@gmail.com |
|
Details of Contact Person Scientific Query
|
| 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 Tharaguppett,
Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9972212417 |
| Fax |
|
| Email |
sandyaraghu@gmail.com |
|
Details of Contact Person Public Query
|
| 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 Tharaguppett,
Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9972212417 |
| Fax |
|
| Email |
sandyaraghu@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, Kalasipalya
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intrathecal 0.25mg of morphine alone in patients undergoing hepatobiliary surgeries under general anaesthesia |
1 ml of 0.25mg morphine with 1 ml of normal saline will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia |
| Intervention |
intrathecal 0.25mg of morphine with 0.5% bupivacaine in patients undergoing hepatobiliary surgeries under general anaesthesia |
1 ml of 0.25mg morphine with 1 ml of 0.5% bupivacaine will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia |
|
|
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 |
Time of requirement of first dose of Tramadol 1mg/kg body weight and total opioid requirement in 24 hrs |
|
|
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 assess hemodynamic parameters intra-operatively and post-operatively till 24 hours |
To assess hemodynamic parameters intra-operatively and at 2,4,8,12,24 hours post-operatively |
| To compare the incidence of side effects such as hypotension, nausea, vomiting, pruritus, cough 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)
|
06/01/2025 |
| 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="1" 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
|
Hepatobiliary surgeries are being performed with increasing frequency due to a rising incidence of hepatobiliary diseases. Effectively administered analgesia not only enables greater patient satisfaction by minimising acute postoperative pain, but through alleviating the acute physiological stress response to surgery, it 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 often considered the gold standard analgesic modality in most peri-operative care programmes for patients undergoing hepatobiliary surgeries as it provides required level of analgesia to support mobilization, significant reduction in pulmonary, cardiovascular and thromboembolic morbidity in early post-operative period and reduced requirement of additional opioid analgesia. Despite its popularity, there exists high rates of epidural failure and concerns on its complications especially since epidural is an invasive, high-cost, labour-intensive technique. Furthermore, there is increased risk of epidural hematoma formation - secondary to coagulation changes after hepatobiliary surgeries, even in patients with normal preoperative coagulation profile. Also it is critical to remove the epidural catheter in a timely manner to minimize complications due to post-operative coagulation disturbances. Given the concerns raised with epidural analgesia in the context of hepatobiliary surgeries, intrathecal anaesthesia has emerged as a promising best practice yielding better patient outcomes as it is a simpler and quicker alternative neuraxial anaesthesia technique, with a lower rate of technical failure. Intrathecal morphine has good analgesic effects with significantly lower failure rates, and other benefits such as decreased postoperative fluid requirements, and shorter postoperative stays. But administration of ITM alone does not adequately prevent the establishment of central sensitization caused by incisional injury—as part of a pre-emptive analgesic strategy, nor assist with low CVP fluid strategies often deployed in these cases. Our hypothesis is that hyperbaric bupivacaine has sufficient cephalad spread to T4, serving as an analgesic bridge prior to the onset of action of intrathecal morphine, thereby lowering opioid requirements intraoperatively and postoperatively. Hence this study aims at prospectively evaluating the potential benefits of the addition of hyperbaric 0.5% bupivacaine to IT morphine 0.25 mg as a spinal regimen for hepatobiliary surgeries done under general anaesthesia.
|