| CTRI Number |
CTRI/2025/05/087082 [Registered on: 19/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| 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
|
Comparison Of Postoperative Pain Relief Following Intraperitoneal Deposition Of Levobupivacaine With And Without Dexmedetomedine In Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Comparison of Postoperative Analgesia Following Intraperitoneal Instillation of Levobupivacaine With And Without Dexmedetomedine In Patient Undergoing Laparoscopic Cholecystectomy |
| 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 Srinivasan S K |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal
PONDICHERRY 609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
9360363321 |
| Fax |
|
| Email |
drsrisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suba L |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room No 2 Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal
PONDICHERRY 609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
9578567506 |
| Fax |
|
| Email |
suba.cutiepie@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suba L |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room No 2 Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal
PONDICHERRY 609609
India
PONDICHERRY
609609
India |
| Phone |
9578567506 |
| Fax |
|
| Email |
suba.cutiepie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka mission medical college,Department of Anaesthesiology,Vinayaka mission medical college and hospital, keezakasakudy medu,karaikal,pondycherry, 609609 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College and Hospital |
| Address |
Vinayaka Missions Medical College and Hospital Keezhakasakudy Medu Kottucherry post Puducherry 609609 |
| 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 Suba L |
Vinayaka Missions Medical College and Hospital |
Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudi,Karaikal
Karaikal
PONDICHERRY |
9578567506
suba.cutiepie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Levobupivacaine |
40ml of 0.25% levobupivacaine alone will be instilled intraperitoneally through the trocar before the closure of abdomen at the end of laparoscopic cholecystectomy.
|
| Intervention |
Levobupivacaine with Dexmedetomidine |
40ml of 0.25% levobupivacaine with 1mcg/kg of dexmedetomidine will be instilled intraperitoneally through the trocar before the closure of abdomen at the end of the laparoscopic cholecystectomy.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Patient undergoing laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
1.ASA III & IV
2.History of allergy to study drug
3.Patients in whom abdominal drain is in-situ
4.Patients who are unable to express VAS score accurately(mentally ill patients)
5.Patient refusal
|
|
|
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 compare the duration of post operative analgesia offered by intraperitoneal Levobupivacaine alone or with dexmedetomidine in patients undergoing laparoscopic cholecystectomy and subsequent need of rescue analgesic |
until first rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total rescue analgesic consumption and Post-operative adverse effects
|
24H |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 3 |
|
Date of First Enrollment (India)
|
27/05/2025 |
| 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 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
|
INTRODUCTION
Laparoscopic
procedures has many advantages over open procedures, such as lesser hemorrhage,
better cosmetic results, lesser post-operative pain, and shorter recovery time,
leading to shorter hospital stay and less expenditure. Postoperative pain is reduced compared to the open surgery, but
effective analgesic treatment after laparoscopic cholecystectomy has remained a
clinical challenge. Local anesthetic instillation in the peritoneal cavity decreases
intensity of postoperative pain after laparoscopic surgeries. INNOVATIVE CONCEPT OF THE PROJECT
Local anaesthetics has been used for control of pain
by intra peritoneal instillation and has become an important addition for
postoperative pain in the era of modern surgery. The role and dosing of
Levobupivacaine and dexmeditomidine is relatively new.
AIM
To
compare the duration of post operative analgesia offered by intraperitoneal
Levobupivacaine alone or with dexmedetomidine in patients undergoing
laparoscopic cholecystectomy.
|