| CTRI Number |
CTRI/2024/07/070534 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| 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
|
Comparison of levobupivacaine alone in one group and adding study drug clonidine with levobupivacaine in another group in patients undergoing laparoscopic gall bladder removal for pain relief after surgery |
|
Scientific Title of Study
|
Comparative evaluation of intraperitoneal instillation of 0.25% levobupivacaine with or without clonidine for postoperative analgesia in patients 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 Saurav Sagar |
| Designation |
Post-graduate resident |
| Affiliation |
ESIC Medical College and Hospital Faridabad |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital NH3 NIT Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
79036338786 |
| Fax |
|
| Email |
sagarsaurav93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop Raj Gogia |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and Hospital Faridabad |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital NH3 NIT Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9810318291 |
| Fax |
|
| Email |
gogiaanoop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurav Sagar |
| Designation |
Post-graduate resident |
| Affiliation |
ESIC Medical College and Hospital Faridabad |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital NH3 NIT Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
7903633876 |
| Fax |
|
| Email |
sagarsaurav93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, 3rd Floor OT Complex, ESIC Medical College and Hospital, NH3, NIT, Faridabad |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia ESIC Medical College and Hospital Faridabad |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital NH3 NIT Faridabad |
| Type of Sponsor |
Other [ESIC Medical College and Hospital, Faridabad] |
|
|
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 Saurav Sagar |
ESIC Medical College and Hospital Faridabad |
Department of Anaesthesiology, 3rd floor OT complex ESIC Medical College and Hospital NH3 NIT Faridabad, PIN code - 121001
Faridabad
HARYANA |
7903633876
sagarsaurav93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESIC Medical College and Hospital, Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine with Clonidine |
Intraperitoneal instillation of 28 ml of 0.25% levobupivacaine with clonidine 0.75 mcg/kg diluted up to 2 ml with normal saline a total volume of 30ml after gall bladder removal 10ml at gall bladder bed, 10ml at hepatoduodenal ligament, 10ml at subdiaphragmatic space before deflation of pneumoperitoneum |
| Comparator Agent |
Levobupivacaine without clonidine |
Intraperitoneal instillation of 28 ml of 0.25% Levobupivacaine + 2 ml normal saline a total volume of 30ml after gall bladder removal 10ml at gall bladder bed, 10 ml at hepatoduodenal ligament, 10ml at subdiaphragmatic space before deflation of pneumoperitoneum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, age 18 to 60 years and belonging to American Society of Anaesthesiologists (ASA) physical status I or II |
|
| ExclusionCriteria |
| Details |
Known allergy to study drugs
Pregnant and lactating females
Procedure converted to open cholecystectomy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of post-operative analgesia after intraperitoneal instillation of clonidine (0.75 mcg/kg) used as an adjunct to 0.25% levobupivacaine vs levobupivacaine alone in patients undergoing laparoscopic cholecystectomy in terms of duration of postoperative analgesia |
At different time intervals during first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total rescue analgesic consumption
2) Postoperative VAS score
3) Mean sedation score
4) Hemodynamic changes – MAP, HR
|
At different time intervals during first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
22/07/2024 |
| 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="3"
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 - NO
|
|
Brief Summary
|
This study is being conducted to compare the efficacy and safety of intraperitoneal instillation of clonidine (o.75mcg/kg) as an adjunct to 0.25% levobupivacaine in patients undergoing laparoscopic surgeries for post-operative analgesia. Patients of either sex, age 18 to 60 years and belonging to American Society of Anaesthesiologists (ASA) physical status I or II. Total 90 patients will be included in the study. Group A (n=45): will receive intraperitoneal instillation of 0.25% Levobupivacaine 28 ml + 2 ml normal saline (total volume = 30 ml); Group B (n =45): will receive intraperitoneal instillation of 0.25% Levobupivacaine 28 ml + Clonidine 0.75 mg/kg diluted with normal saline up to 2 ml (total volume = 30 ml). Assessment of postoperative pain using 10 point visual analogue scale (VAS) score (Score 0: no pain and Score 10: worst possible pain) at 30 mins, 1 hour, 2hours 6 hours,12 hours and 24 hours after surgery. Diclofenac sodium aqueous (75 mg IV) will be given as rescue analgesic when VAS ≥4 or on patient demand.
|