| CTRI Number |
CTRI/2024/02/062237 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two approaches of pain relief after laparoscopic gall bladder removal surgery |
|
Scientific Title of Study
|
Comparison of 0.25% Ropivacaine for Intraperitoneal Instillation versus ultrasound guided Rectus Sheath Block for Postoperative Pain Relief Following 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 Parampreet Kaur |
| Designation |
Junior resident |
| Affiliation |
Teerthanker Mahaveer Medical college and research centre |
| Address |
Room no.204 , Department of Anaesthesia , Teerthanker Mahaveer Medical college and research centre,Delhi road,moradabad ,uttarpradesh.
2nd floor ,Department of anaesthesia ,TMMC&RC ,Moradabad.
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7814120162 |
| Fax |
|
| Email |
pumjuneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical college and research centre |
| Address |
Room no 201, Department of anaesthesia ,Teerthanker Mahaveer Medical college and research centre,N.H-24 ,Delhi road, Moradabad .
2nd floor ,Department of anaesthesia ,TMMC&RC ,Moradabad.
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
989797372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh kumar prasad |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical college and research centre |
| Address |
Room no. 204 , Department of anaesthesia ,Teerthanker Mahaveer Medical college and research centre,N.H-24 ,Delhi road, Moradabad .
2nd floor ,Department of anaesthesia ,TMMC&RC ,Moradabad.
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical college and research centre, Moradabad UP |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical college and research centre |
| Address |
Dept of anaesthesia, Teerthanker Mahaveer Medical college and research centre |
| Type of Sponsor |
Private 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 Parampreet kaur |
Teerthanker Mahaveer Medical college and research centre |
Department of anaesthesia, room no.4 ,2nd floor,Teerthanker Mahaveer Medical college and research centre,Delhi road,moradabad ,up.
Moradabad
UTTAR PRADESH |
7814120162
pumjuneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% Ropivacaine |
GROUP I -: will receive Intraperitoneal Instillation of 0.25 % injection Ropivacaine 30 ml along with injection Paracetamol 15mg/kg IV.
GROUP R -: will receive Ultrasound guided Rectus Sheath Block with 0.25 % injection Ropivacaine 15 ml on either side along with injection Paracetamol 15mg/kg IV.
|
| Intervention |
Intraperitoneal instillation with inj Ropivacaine 0.25% 30 ml. |
GROUP I -: will receive Intraperitoneal Instillation of 0.25 % injection Ropivacaine 30 ml after induction through epigastric port. |
| Intervention |
Ultrasound guided rectus sheath block with inj Ropivacaine 0.25% 30 ml. |
Group -R will receive Ultrasound guided rectus sheath block with injection 0.25% Ropivacaine 15ml on each side before the start of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA (american society of anaesthesiologists) physical status I-III.
Patients posted for elective laparoscopic cholecystectomy.
BMI between 18.5-24.9 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients refusal
hypersensitivity or allergic to local anaesthetics
Acute cholecystitis
Patient with associated cardio respiratory illness
Conversion to open cholecystectomy
If patient is unable to understand or use VAS scale |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the post-operative pain assessed using VAS (visual analogue scale) between both groups.
To compare the post-operative pain assessed using (PHHPS) Prince Henry Hospital Pain Score between both groups. |
30 min, 1hr, 2h, 4h,6h, 12h, 24h and 48h after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between visual analogue scale (VAS) and Prince Henry Hospital Pain Score (PHHPS) between both groups.
To compare hemodynamic parameters (SpO2, heart rate, mean arterial pressure, systolic blood pressure, diastolic blood pressure, respiratory rate) between both groups. |
30 min, 1hr, 2h, 4h,6h, 12h, 24h and 48h after surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/02/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ropivacaine is a newer amide which has less risk of cardiovascular toxicity and central nervous system side effects. Intraperitoneal instillation with ropivacaine 0.25% can provide postoperative pain relief following laparoscopic cholecystectomy.Ultrasound guided blocks give better visualisation of the relevent anatomy and give us accurate placement of local anaesthetic drug and also the spread of local anaesthetic can be seen. Comparison of ultrasound guided rectus sheath block with intraperitoneal instillation of 0.25% ropivacaine in reducing postoperative pain in patients after elective laparoscopic cholecystectomy will be done |