| CTRI Number |
CTRI/2025/07/090252 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| 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 Postoperative analgesia with Block And Pre-incisional Port Site Local Infiltration In Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Comparison Between Ultrasound Guided Bilateral External Oblique Intercostal Plane Block And Pre-incisional Port Site Local Infiltration For Postoperative Analgesia in 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 |
Gandev J Chaudhari |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Baroda |
| Address |
Department of anaesthesiology Government Medical college Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
8758388805 |
| Fax |
|
| Email |
bhagatgandev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Nimisha Brahmbhatt |
| Designation |
Professor and HG |
| Affiliation |
Government Medical College Baroda |
| Address |
Department of anaesthesiology Government Medical college Baroda
Vadodara
GUJARAT
39001
India |
| Phone |
9428764477 |
| Fax |
|
| Email |
nimishabrahmbhatt7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Nimisha Brahmbhatt |
| Designation |
Professor and HG |
| Affiliation |
Government Medical College Baroda |
| Address |
Department of anaesthesiology Government Medical college Baroda
Vadodara
GUJARAT
39001
India |
| Phone |
9428764477 |
| Fax |
|
| Email |
nimishabrahmbhatt7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology
Government Medical College
Baroda,Gujarat,India-390001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Baroda |
| Address |
Department Of Anaesthesiology
Government Medical College
Baroda,Gujarat,India-390001 |
| Type of Sponsor |
Government 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 |
| DrGandev J Chaudhari |
Government Medical Collee Baroda |
2nd floor,General surgery operation theatre,Department of surgery,Government.Medical College,Baroda,Gujarat,india-390001
Government Medical College
Baroda
Vadodara
GUJARAT |
8758388805
bhagatgandev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee For Biomedical And Health Research Government Medical College Baroda |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison between ultrasound guided bilateral external oblique intercostal plane block and pre-incisional port site local infiltration for post-operative analgesia in adult patients undergoing laparoscopic cholecystectomy |
After the patient intubation 5ml of 0.25% bupivacaine will be injected at every port (epigastric port, umbilical port, and for both working ports) in various tissue planes (skin, subdermal, subfascial, and peritoneal) under direct visualization of incision site by operating surgeon.
Comparison of Postoperative analgesic effect will be assess till 24hours.
|
| Intervention |
Comparison between ultrasound guided bilateral external oblique intercostal plane block and pre-incisional port site local infiltration for post-operative analgesia in adult patients undergoing laparoscopic cholecystectomy |
Block will be given after general anaesthesia.
The patient is placed in the supine position. After induction of anaesthesia, skin is cleaned with 5% Povidone Iodine solution and then draping is done, under all aseptic and antiseptic precaution, a linear ultrasound transducer will be placed medial to anterior axillary line at the level of sixth rib. The location of sixth rib will be identified by counting down approach from the second rib or by placing transducer at the level of the xiphoid process, which corresponding to sixth rib.
The ecoplex needle will be inserted using out plane technique. After piercing skin needle will be advanced through skin from cephalad to caudad direction, the fascial plane between the external oblique muscle and intercostal muscle will be identified and needle tip position will be confirmed by hydrodissection with 1.0ml sterile water. Following a negative aspiration 20ml 0.25% bupivacaine local will be injected at plane between external oblique intercostal muscle above and sixth rib below.
The identical method will be followed on the opposite side. Total 40ml drug will be given on bilateral site.
Comparison of Postoperative analgesic effect will be assess till 24hours.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years
ASA Grade One And TWO
patient schedule for elective laparoscopic cholecystectomy
patient able to give verbal and informed consent
patient able to understand VAS regarding assessment of pain
|
|
| ExclusionCriteria |
| Details |
Refusal of patient
History of allergy to local anaesthetic drug
Skin infection at puncture site
Coagulation disorders
Cardio pulmonary/hepatorenal disease
Pregnancy
|
|
|
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 |
Time to assess first rescue analgesia (Inj. Tramadol in 2mg/kg)
Time interval from block performance to requirement of first rescue analgesia.
Time interval from block performance to requirement of first rescue analgesia.
|
Till 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate post operative analgesia using visual analogue scale (VAS) measured at 0,1,2,4,6,8,12,18,24 hours at rest and on movement
Intra-operative dexmedetomidine requirement
Post-operative total requirement of analgesic drugs in 24 hours
To assess hemodynamic parameter
To assess patient satisfaction score (Likert scale)
complications related to block
|
Till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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 4 |
|
Date of First Enrollment (India)
|
18/07/2025 |
| 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="0"
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
|
The Purpose of this study is to compare
post-operative analgesia after Bilateral External Oblique Intercostal Plane
Block and Pre-incisional port site local infiltration, postoperative total
requirenment of analgesic drugs, assess hemodynamic parameter, early recovery in
adult patients undergoing laparoscopic cholecystectomy. The patients
will be randomly allocated into two groups by using computerised randomisation
in a 1:1 ratio to undergo bilateral ultrasound guided external oblique
intercostal plain block and pre-incisional port-site instillation of local
anaesthetics.
In group B,
patient will be given bilateral ultrasound guided external oblique intercostal
plane block after giving general anaesthesia.
In
group L, patient will be given pre-incisional port-site local infiltration
after giving general anaesthesia.This study
may superior in post operative analgesia with higher safety margin in
patients laparoscopic cholecystectomy with ultrasound guided
bilateral external oblique intercostal plane block as a part of multimodal
analgesia.
|