| CTRI Number |
CTRI/2021/09/036959 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two approved ways of post operative pain relief for patients undergoing gall bladder surgery |
|
Scientific Title of Study
|
Efficacy of ultrasound guided bilateral subcostal transverse abdominis plane block against port site local infiltration in providing post operative analgesia in laparoscopic cholecystectomy patients - A randomised open label trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanya P T |
| Designation |
Postgraduate |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of anesthesia,Bangalore Baptist Hospital, Bellary Rd,Vinayakanagar, Hebbal, Bangalore.
Bangalore
KARNATAKA
560024
India |
| Phone |
9148947065 |
| Fax |
|
| Email |
dpt1234567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpalatha D S |
| Designation |
Consultant |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of Anesthesia, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9480332021 |
| Fax |
|
| Email |
pushpa.bettari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushpalatha D S |
| Designation |
Consultant |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of Anesthesia, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9480332021 |
| Fax |
|
| Email |
pushpa.bettari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Baptist Hospital |
|
|
Primary Sponsor
|
| Name |
Bangalore baptist Hospital |
| Address |
Vinayakanagar, Hebbal, Bangalore |
| 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 |
| Dhanya P T |
Bangalore Baptist Hospital |
Department of Anesthesiology
Bangalore
KARNATAKA |
9148947065
dpt1234567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board, Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (4) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (5) ICD-10 Condition: K810||Acute cholecystitis, (6) ICD-10 Condition: K811||Chronic cholecystitis, (7) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A- Bilateral subcostal Transverse Abdominis Plane Block with 20ml 0.25% bupivacaine each side |
A high frequency linear array transducer with frequency ranging from 15 to 16 MHz sonosite probe with sterile drape is used. USG transducer will be placed over midline to identify rectus muscle and moved to lateral side until it reaches the plane between the internal oblique muscle and transverse abdominis muscle.An appropriate sized 22 gauge short beveled insulated nerve block needle is introduced in this plane.Accurate needle position will be confirmed with 1-2ml saline injection(hydrodissection).
20ml of 0.25% bupivacaine is injected in the same plane after confirming the plane by hydrodissection.The same procedure will be repeated in the opposite side |
| Comparator Agent |
Group B - Port site local infiltration with 0.5 ml bupivacaine 7ml each at periumbilical and subxiphoid port ,3ml each at anterior axillary and mid-clavicular port site. |
Port site local infiltration will be performed by the surgeon using 20ml of 0.5% bupivacaine .7ml of the drug will be injected at periumbilical port site, 7ml at subxiphoid port, 3ml at anterior axillary and 3ml at midclavicular port site. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA (American Society of Anesthesiologists) physical status 1,2 and 3 posted for all elective and emergency surgeries. |
|
| ExclusionCriteria |
| Details |
1)Refusal to give consent for the study/procedure
2)Allergic to local anesthetic agents
3)Skin conditions precluding the block
4)Preoperative chronic dependence upon opioid medications
5)Conversion to open technique or performance of any other surgical procedure . |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Efficacy of postoperative analgesia as evaluated by numerical rating scale
2)Total opioid requirement in first 24 hrs post operatively |
1)Efficacy of postoperative analgesia as evaluated by numerical rating scale in first 24 hrs
2)Total opioid requirement in first 24 hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of any side effects |
For first 24 hrs. |
| Total rescue analgesic used |
Within first 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
10/10/2021 |
| 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
|
Not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the analgesic efficacy of ultrasound guided bilateral subcostal transverse abdominis plane block with that of port-site infiltration in providing post operative analgesia in patients undergoing laparoscopic cholecystectomy. The patients undergoing laparoscopic cholecystectomy will be randomly allocated into two groups. One group will receive ultrasound guided bilateral subcostal transverse abdominis plane block where as the other group will receive port-site local infiltration before surgery. Then the two groups will be assessed for post operative pain using numerical rating scale scores, use of any rescue analgesics and total opioid requirement in first 24 hrs post operatively. Any adverse events following the procedure will be noted. |