| CTRI Number |
CTRI/2019/01/017255 [Registered on: 25/01/2019] Trial Registered Prospectively |
| Last Modified On: |
28/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Compare Nerve block in Right Upper Side of Abdomen Performed using Ultrasound and Laparoscopy for Postoperative Pain Relief |
|
Scientific Title of Study
|
Comparison of Laparoscopic guided with Ultrasound Guided Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy – A Prospective, Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajagopalan Venkatraman |
| Designation |
Professor |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajagopalan Venkatraman |
| Designation |
Professor |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meshach M Dhas |
| Designation |
Postgraduate Student |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9489618237 |
| Fax |
|
| Email |
meshachmdhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology |
|
|
Primary Sponsor
|
| Name |
SRM medical College Hospital |
| Address |
Room no 1, B Block, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMIL NADU |
| 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 |
| Rajagopalan Venkatraman |
SRM medical college hospital |
Department of Anaesthesiology Srm Medical College Hospital Potheri
Kattankulathur
Kancheepuram
TAMIL NADU |
9894581455
drvenkat94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laparoscopic guided Subcostal TAP BLock |
The nerve block performed between internal oblique and transversus abdominis muscle below the costal margin under visualisation with laparosopy. |
| Intervention |
Ultrasound guided Subcostal TAP Block |
The nerve block performed between internal oblique and transversus abdominis muscle below the costal margin under ultrasound guidance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with ASA Physical Status I and II posted for unilateral laparoscopic cholecystectomy.
2. Weighing between 60 – 100 kg
|
|
| ExclusionCriteria |
| Details |
1. All patients with ASA Physical Status III and above
2. Patients who refuse to participate in the study
3. Patients who are allergic to amide local anaesthetics
4. Patients who are pregnant
5. Patients with chronic cardiac, renal or hepatic condition
6. Patients with coagulation abnormalities
|
|
|
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 |
| Duration of postoperative analgesia |
Time taken from the block completion to the first request for postoperative analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Consumption of analgesics |
Total consumption of Morphine in the PCA pump for 24 hours is calculated |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2019 |
| Date of Study Completion (India) |
30/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients posted Laparoscopic cholecystectomy that fulfills the inclusion criteria will be enrolled in this study after obtaining ethical committee clearance. Patients will be randomly allocated into two groups, Group A and Group B, with 40 patients in each group. At the end of surgery, Group A patients will receive Ultrasound guided bilateral subcostal Transversus Abdominis Plane (TAP) block with Ropivacaine 0.2% 20 ml. Group B patients will receive laparoscopic guided bilateral subcostal TAP block with Ropivacaine 0.2% 20 ml. The patient will be monitored by the anaesthesiologist in PACU who will be blinded to the group involved. All patients will be premedicated with Tab. Alprazolam 0.5 mg PO 2 hrs before being shifted to the operating theatre. Patient’s vitals will be monitored with pulse oximetry, NIBP, and ECG. All the patients will receive general anaesthesia with endotracheal intubation which will be standardized. Patients will be induced with Propofol 2mg/kg and vecuronium 0.1 mg/kg as the muscle relaxant. Morphine 0.15 mg/kg iv will be the intraoperative analgesic. Anaesthesia will be maintained with Sevoflurane and vecuronium.
At the end of surgery, the patient will receive either ultrasound (Group A) or laparoscopic guided (Group B) TAP block. After taking proper aseptic precautions, TAP block will be given using 20 ml of 0.2% Ropivacaine. The patient will be extubated after performing the block and shifted to recovery. The patient will be shifted to PACU when Aldrete recovery criteria are satisfied. The patient will be continuously monitored in PACU for 24 hours. The pain will be assessed by visual analog scale (VAS), measured at rest with 0 being no pain and 10 being worst pain possible. The duration of postoperative analgesia is defined as the time taken from the completion of TAP block to the first request for postoperative analgesia (VAS > 3). The patient will be started on Patient Controlled Analgesia pump with morphine bolus dose of 1 mg and lockout interval of 10 minutes. The patient will be instructed to have bolus when VAS is more than 3. The total consumption of morphine is noted. The occurrence of any adverse effects like nausea, vomiting, itching and respiratory depression will be noted and treated accordingly. |