| CTRI Number |
CTRI/2020/10/028603 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
01/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of peripheral regional blocks with ultrasonography for post operative pain relief in laparoscopic cholecystectomy patients |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of Ultrasound guided Erector Spinae Block with Oblique Subcostal Transverse Abdominis plane block after laparoscopic Cholecyctectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha Devanand |
| Designation |
PG student |
| Affiliation |
BJ Medical College and Hospital |
| Address |
e106, Phase 1 PG Hostel, Civil Hospital Campus, Asarwa
Civil Hospital Campus
Asarwa
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
8921097072 |
| Fax |
|
| Email |
ashadevanand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
BJ Medical College and Hospital |
| Address |
F3, department of anaesthesia, Civil Hospital, asarwa
Civil Hospital Campus
Asarwa
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
BJ Medical College and Hospital |
| Address |
F3, Department of Anaesthesia
Civil Hospital,
Asarwa, Ahmedabad
Civil Hospital Campus
asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BJ Medical College and Civil Hospital, Ahmedabad, Gujarart |
|
|
Primary Sponsor
|
| Name |
Dr Asha Devanand |
| Address |
PG Hostel
Civil Hospital Campus
Asarwa, Ahmedabad, Gujarat |
| 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 Asha Devanand |
General surgery operation theater |
F3, first floor, general surgery operation theatre, civil hospital, Asarva, Ahmedabad
Ahmadabad
GUJARAT |
8921097072
ashadevanand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, B.J. Medical College and Civil Hospital, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (4) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, (5) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis, (6) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (7) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (8) ICD-10 Condition: K808||Other cholelithiasis, (9) ICD-10 Condition: K820||Obstruction of gallbladder, (10) ICD-10 Condition: K821||Hydrops of gallbladder, (11) ICD-10 Condition: K822||Perforation of gallbladder, (12) ICD-10 Condition: K824||Cholesterolosis of gallbladder, (13) ICD-10 Condition: K828||Other specified diseases of gallbladder, (14) ICD-10 Condition: K810||Acute cholecystitis, (15) ICD-10 Condition: K811||Chronic cholecystitis, (16) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (17) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparision of postoperative analgesia using USG guided erecter spinae block or subcostal TAP block |
USG guided erector spnae block or subcostal TAP block at the end of surgery to be given and for 24 hours duration of postoperative analgesia will be observed |
| Intervention |
USG guided Erector Spinae Plane Block or Subcostal Transverse Abdominis Plane Bock |
for Post operative analgesia either erect spine block or subcostal TAP block to be given and the patient to be observed for a period of 24 hours for analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
patient refusal, ASA III-IV, contraindication to regional anaesthesia, bleeding diathesis
use of anticoagulants, hypertension, known allergy to local anaesthetics, advanced hepatic or renal failure, advanced psychiatric illness, obesity- bmi>35kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| analgesic efficacy to be measured by numeric rating scale |
at the end of surgery as block given to 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total rescue analgesic consumption in 24 hours, hemodynamic parameters and any complications |
postoperative 20 minutes after giving block to 24 hours follow up |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2020 |
| Date of Study Completion (India) |
28/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published on 26th November 2022 in Ain Shams Journal of Anaesthesiology |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Laparoscopic cholecystectomy is a frequently done minimally invasive surgery. It causes moderate to severe post operative pain. This pain has three components. Somatic pain, local visceral pain and referred visceral pain. Laparoscopic cholecystectomy leads to somatic pain from the supraumbilical abdominal area and visceral pain due to pneumoperitoneum and surgical manipulation. Ultrasound guided erector spinae plane block (ESPB) is a recently described technique targeting the ventral rami, dorsal rami and rami communicantes of spinal nerves. It is an effective method for the blockage of both somatic and visceral pain and easier to perform compared to neuraxial, nerve plexus, and targeted nerve blocks. OSTAP leads to only blockage of somatic pain and the deeper fibres of the anterior and lateral cutaneous branches of 7th to 11th thoracic intercostal nerves which partially innervate the parietal peritoneum because of which it has an effect on visceral pain.
In this study we aim to compare the analgesic efficacy of oblique subcostal transverus abdominis block and erector spinae plane block. |