| CTRI Number |
CTRI/2025/02/080675 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using the medicine Ondansetron inside the Abdomen during surgery to help with Pain after Gallbladder Surgery |
|
Scientific Title of Study
|
Intraperitoneal ondansetron for postoperative analgesia in
laparoscopic/robotic cholecystectomy : a double-blinded, 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 |
Mohd Sharib Wahaj |
| Designation |
Junior Resident, Department of surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) , Pondicherry |
| Address |
Department of surgery , old block , Jipmer Campus, Dhanvantari nagar ,Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9818727697 |
| Fax |
|
| Email |
sharib3199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Kate |
| Designation |
Professor (Senior Scale), Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry |
| Address |
Academic block ,Jipmer Campus, Dhanvantari nagar ,Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Kate |
| Designation |
Professor (Senior Scale), Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry |
| Address |
Academic block , Jipmer Campus, Dhanvantari nagar ,Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research.
Department of surgery , Old block , JIPMER campus , Dhanvantri nagar , Puducherry- 605006 , India |
|
|
Primary Sponsor
|
| Name |
Mohd Sharib Wahaj |
| Address |
Jipmer campus road, Dhanvantari nagar, Puducherry, 605006 |
| Type of Sponsor |
Other [Self] |
|
|
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 Mohd Sharib Wahaj |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of surgery , old block , Jipmer Campus, Puducherry, 605006
Pondicherry
PONDICHERRY |
9818727697
sharib3199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-INTERVENTIONAL STUDIES JIPMER, PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Receiving normal saline (Group B) |
Subjects will be administered with 2ml of normal saline stat intraperitoneally in the gall bladder bed at the end of procedure. |
| Intervention |
Receiving ondansetron (Group A) |
Subjects will be administered with 4mg ondansetron (2ml) stat intraperitoneally in the gall bladder bed via irrigation at the end of procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients more than 18 years planned for laparoscopic and robotic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
1.Patients who have liver or renal dysfunction.
2.Patients who have chronic pain other than symptomatic cholelithiasis.
3.Patients who have history of daily intake of corticosteroids or a history of allergy to any of the study drugs.
4.Patients with communication problems, cognitive dysfunction, or psychological disorders.
5.Patients who received analgesics or sedatives 24 h before a scheduled surgery.
6.All pregnant/lactating females
7.Patients undergoing concomitant surgeries
8.Minimally invasive procedure converted to open procedure
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy in pain relief from baseline to 12, and 24 hours post-operatively in the study population |
To evaluate the efficacy in pain relief from baseline to 12, and 24 hours post-operatively in the study population |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the differences between study groups in Time to first rescue analgesic request
Cumulative consumption of rescue analgesic postoperative period till discharge.
Time for unassisted mobilization.
|
Cumulative dose of rescue analgesia required in 24 hours, time to first recue analgesia request and time to unassisted mobilization. |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sharib3199@gmail.com].
- For how long will this data be available start date provided 21-01-2025 and end date provided 21-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Laparoscopic/robotic cholecystectomy is a frequently performed surgery for various gallbladder conditions, particularly gallstones. It is considered the standard technique for addressing benign biliary diseases. However, managing pain post-surgery presents a significant challenge due to its multifaceted nature. Local irritation caused by carbon dioxide intraperitoneal administration during the procedure, coupled with increased intra-abdominal pressure, contributes to postoperative pain. Traditionally, opioids have been the go-to option for postoperative pain relief, despite their side effects like vomiting and respiratory depression. To address this, multimodal pain management has become popular to lower opioid doses and side effects. Recent studies suggests that 5-HT3 antagonists, which impact serotonin, may have anti-inflammatory and pain-relieving properties. These drugs act on serotonin receptors to alleviate pain and may also bind to opioid receptors, acting as opioid-like pain relievers. Ondansetron, a 5-HT3 antagonist, might also block sodium channels, further aiding its pain-relieving effects. This suggests that 5-HT3 antagonists could be a promising new class of local anesthetics.
However, there have been a very few studies reporting the efficacy of ondansetron in alleviating post-laparoscopic & robotic cholecystectomy pain. Hence , in the present study we aim to conduct a prospective randomised controlled trail to assess the impact of intraperitoneal ondansetron administration as an adjunct to intravenous acetaminophen for postoperative pain management in patients undergoing laparoscopic & robotic cholecystectomy.
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