| CTRI Number |
CTRI/2024/07/070506 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Managing post operative pain using Bilateral Subcostal Block Plus Lateral Transversus Abdominis Plane Block In Patients Undergoing Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Efficacy Of Bilateral Subcostal Plus Lateral Transversus Abdominis Plane Block For Post Operative Analgesia In Patients 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 |
Dr Shubhika Singh |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of Anesthesiology Critical Care, Pain and Palliative Medicine, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7409709345 |
| Fax |
|
| Email |
drshubhika2904@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Bhandari |
| Designation |
Professor and HOD, Department of anaesthesiology |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of Anesthesiology Critical Care, Pain and Palliative Medicine, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
8650655556 |
| Fax |
|
| Email |
bhandari_geetantl@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Bhandari |
| Designation |
Professor and HOD, Department of anaesthesiology |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of Anesthesiology Critical Care, Pain and Palliative Medicine, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
8650655556 |
| Fax |
|
| Email |
bhandari_geetantl@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sushila Tiwari Hospital Haldwani ,Nainital, Uttarakhand, India
Pin code- 263139 |
|
|
Primary Sponsor
|
| Name |
Dr. Shubhika Singh |
| Address |
Department of Anaesthesiology, Dr Susheela Tiwari government hospital, Rampur road, Haldwani Uttarakhand 263139 |
| 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 Shubhika Singh |
Dr. Susheela Tiwari Hospital |
Department of Anesthesiology Critical Care, Pain and Palliative Medicine, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL |
7409709345
drshubhika2904@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMC Haldwani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
B/L subcostal plus lateral TAP block and Sham block |
The study population will be divided into 2 groups. The control(second group) will be given the bilateral subcostal plus lateral TAP block with normal saline after removal of gall bladder in laparoscopic cholecystectomy. All the parameters like postoperative VAS Score, QoR-40 score, intraoperative hemodynamic changes (HR, SBP, DBP,MAP) will be recorded. Postoperative pain score monitoring will be done using the VAS score at 30 mins ,2,4,8,12 and 24 hours after surgery. And at 24 hours after the surgery, and quality of Recovery-40 score will be completed by the patient. |
| Intervention |
B/L subcostal plus lateral TAP block and Sham block |
The study population will be divided into 2 groups. the first group will be given bilateral subcostal and lateral TAP block with 0.25% Bupivacaine with multimodal analgesia under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient giving consent
2. All Patients aged 18yrs -60 yrs
3. Both genders
4. ASA I & II undergoing laparoscopic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
1. Refusal of informed consent
2. Allergic to local anesthetic agent
3. Skin conditions precluding the block
4. Preoperative chronic dependence upon opioid medication
5. BMI less than 25 kg/m2
6. History of cardiovascular diseases . |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of bilateral subcostal plus lateral transversus abdominis plane using VAS
and QoR-40 score in post operative period against the control group undergoing laparoscopic
cholecystectomy. |
till 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
â— Visual analogue scale(VAS) score and QOR-40 Score
â— Duration of analgesia
â— Hemodynamic changes
â— Rescue analgesia |
till 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
20/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 present study is prospective, Randomized and comparative study done after approval of Institutional Ethics Committee in patients satisfying all inclusion and exclusion criteria planned for laparoscopic cholecystectomy under general anaesthesia. Multi para monitors , 0.25% Bupivacaine,VAS Score, QoR-40 Score and normal saline 0.9 % will be used as study tools.
The study population will be divided into two groups of 29 each . The first group will be given bilateral subcostal plus TAP block using local anaestheic agent and the second group will be given bilateral subcostal plus lateral TAP block using normal saline instead of local anaesthetic agent . All the parameters like postoperative VAS Score, QoR-40 score, intraoperative hemodynamic changes (HR, SBP, DBP,MAP) will be recorded. Postoperative pain score monitoring will be done using the VAS score at 30 mins ,2,4,8,12 and 24 hours after surgery. And at 24 hours after the surgery, VAS and quality of Recovery-40 score will be completed by the patient. |