CTRI Number |
CTRI/2019/11/022006 [Registered on: 14/11/2019] Trial Registered Prospectively |
Last Modified On: |
06/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of postoperative analgesic effect between ultrasound guided transverse abdominis plane block and local infiltration of local anaesthesia-bupivacaine 0.5% at port site in patients undergoing laparoscopic cholecystectomy. |
Scientific Title of Study
|
Comparison of postoperative analgesic efficacy between ultrasound guided transverse abdominis plane block and local infiltration of bupivacaine 0.5% at port site in laparoscopic cholecystectomy. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mathi Sri Akshay |
Designation |
MBBS |
Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
Address |
Department of general surgery,Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai TAMIL NADU 600116 India |
Phone |
9640737722 |
Fax |
|
Email |
sriakshaymathi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Arulappan T |
Designation |
MS General surgery |
Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
Address |
Department of General surgery, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai TAMIL NADU 600116 India |
Phone |
9841215453 |
Fax |
|
Email |
arulappant9@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Arulappan T |
Designation |
MS General surgery |
Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
Address |
Department of General surgery,Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai TAMIL NADU 600116 India |
Phone |
9841215453 |
Fax |
|
Email |
arulappant9@gmail.com |
|
Source of Monetary or Material Support
|
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
|
|
Primary Sponsor
|
Name |
Sri Ramachandra Institute of Higher Education and Research Deemed to be University |
Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),Porur, Chennai, Tamil Nadu, 600116 |
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 |
Mathi Sri Akshay |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
Department of general surgery, 2 nd floor link, Gblock,Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai TAMIL NADU |
9640737722
sriakshaymathi@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee, Sri Ramachandra institute of higher education |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Transverse abdominis plane block is compared with port site infiltration of local anaesthesia in postoperative period as analgesic agent in patients undergoing laparoscopic cholecystectomy |
Participants in study were divided into two groups group-A and B. Group-A:- Allotted drug(Bupivacaine 0.5%) for this group will be delivered in the transverse abdominis plane by another anaesthesiologist who is well versed in giving blocks with the aid of an ultrasound. Ultrasound guided subcostal transverse abdominis plane block will be performed bilaterally before surgical incision. Ultrasound probe will be placed transversely in the midaxillary line below the costal margin. The external oblique, internal oblique and transverse abdominis muscle and their fascia will be visualised. A 100 mm needle will be introduced anteriorly and in the plane of the probe and on entering the transverse abdominis plane, 2 ml of saline will be injected to verify the correct position of the needle. After negative aspiration, 20 ml of study drug will be injected and the separation of fascial layer between transverse abdominis and internal oblique is considered as proper placement of the drug. Similarly, subcostal transverse abdominis plane block will be done on the contralateral side. Group-b:- allotted drug for this group will be delivered subcutaneously 5ml at each of the four port sites.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients with calculus cholelithiasis.
ASA I, II, III. |
|
ExclusionCriteria |
Details |
Patient non compliance
Heart rate<60 bpm
Baseline systolic bp <100mmhg
BMI<18 or >35 kg/m2
Allergic to study drugs
Infection at injection site
Coagulopathy
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr.
If pain score more than 4, rescue analgesia will be given.
Inj Paracetamol 1 gm IV will be first line analgesic.
If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic. |
Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr.
If pain score more than 4, rescue analgesia will be given.
Inj Paracetamol 1 gm IV will be first line analgesic.
If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Postoperative Spo2 monitoring will be done for every 30mins for first 24hrs. |
Postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr. |
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
25/11/2019 |
Date of Study Completion (India) |
16/06/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
11/06/2020 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This study will be published after completion of study |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Patients coming for laparoscopic cholecystectomy who fit into the inclusion criteria will be included in the study. Patients enrolled in the study will be explained about the study drugs and the possible advantages and disadvantages and their consent will be obtained. Patients will be assessed on the previous day and nil per oral orders for atleast 8 hours will be maintained. On day of surgery, patient will be brought to the or , baseline monitors will be connected and baseline vitals will be recorded. The study drugs will be prepared by an anaesthesiologist who is not involved in the study. Group-A:- allotted drug for this group will be delivered in the transverse abdominis plane by another anaesthesiologist who is well versed in giving blocks with the aid of an ultrasound. Ultrasoundguided subcostal transverse abdominis plane block will be performed bilaterally before surgical incision. Ultrasound probe will be placed transversely in the midaxillary line below the costal margin. The external oblique , internal oblique and transverse abdominis muscle and their fascia will be visualised. A 100 mm needle will be introduced anteriorly and in the plane of the probe and on entering the transverse abdominis plane , 2 ml of saline will be injected to verify the correct position of the needle. After negative aspiration , 15 ml of study solution will be injected and the separation of fascial layer between transverse abdominis and internal oblique is considered as proper placement of the drug. Similarly subcostal transverse abdominis plane block will be done on the contralateral side. Group-B:- allotted drug for this group will be delivered Subcutaneously 5ml at each of the four port sites. Intraoperative haemodynamics will be monitored and recorded . We will assess the post operative pain and the need for rescue analgesics in the immediate post operative period. If vas score >4 in the post anaesthesia care unit(1hr post operatively) in patients who received tap block will be considered to have block failure and such patients will be excluded from the study. Analysis Pain to be assessed using visual analogue scale(vas). Pain scores to be assessed at 30mins, 1hr,2hrs, 4 hrs, 8 hrs. If pain score more than 4, rescue analgesia will be given. Post operative spo2 monitoring every 30mins, for 24hrs. rescue analgesia Inj paracetamol 1 gm iv, if no relief with inj paracetamol in 30 min Inj diclofenac 75mg im will be given . primary outcome Vas score post operatively Duration of post operative analgesia (duration is the time from performance of block/local infiltration to the first pain score =>4 . ) secondary outcome Time for first rescue analgesia Number of doses of rescue analgesia given Postoperative oxygen saturation monitoring. |