| CTRI Number |
CTRI/2019/05/019020 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
07/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided injection in the anterior abdominal wall intermuscular plane for pain relief after laparascopic gall bladder surgery: Local anesthetic vs Local anesthetic plus dexamethasone. |
|
Scientific Title of Study
|
Ultrasound guidede bilateral subcostal transversus abdominis plane block for postoperative analgesia after laparoscopic cholecystectomy:a comparative study of 0.25% levobupivacaine vs 0.25% levobupivacaine with dexamethasone. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshika Agarwal |
| Designation |
Post Graduate Student |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Department of Anesthesiology and Pain Medicine, 2nd Floor OT Complex
Medica Superspecialty Hospital, 127, Mukundapur , E.M. Bypass,Kolkata
Kolkata
WEST BENGAL
700099
India |
| Phone |
8763208729 |
| Fax |
|
| Email |
anshikaagarwal1005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaya Choudhary |
| Designation |
Senior Consultant |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Dept. of Anesthesiology and Pain Medicine, 2 nd Floor OT Complex,
Medica Superspecialty Hospital, 127, Mukundapur , E.M. Bypass,Kolkata
Kolkata
WEST BENGAL
700099
India |
| Phone |
8017517100 |
| Fax |
|
| Email |
jayachoudhry11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaya Choudhary |
| Designation |
Senior Consultant |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Dept of Anesthesiology and Pain Medicine, 2nd Floor OT Complex,
Medica Superspecialty Hospital, 127, Mukundapur , E.M. Bypass,Kolkata
Kolkata
WEST BENGAL
700099
India |
| Phone |
8017517100 |
| Fax |
|
| Email |
jayachoudhry11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medica Superspecialty Hospital |
| Address |
127, Mukundapur, E.M.Byepass, Kolkata 700099 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Anshika Agarwal |
Medica Superspecialty hospital |
Dept of Anesthesiology and Pain Medicine, 2nd Floor , OT Complex,
127, Mukundapur,E.M.Bypass , Kolkata
Kolkata
WEST BENGAL |
08763208729
anshikaagarwal1005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee- Medica Superspecialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided Bilateral Transversus Abdominis Plane Block with 0.25% Levobupivacaine vs 0.25% Levobupivacaine with 4 mg Dexamethasone. |
76 Patients will be randomly divided into two groups of 38 each. Group1 will receive 20 ml 0.25% Levobupivacaine with 1 ml Normal Saline on each side. Group 2 will receive 20 ml 0.25% Levobupivacaine with 4 mg Dexamethasone on each side. The effect of the comparator agent Dexamethasone on the duration and quality of analgesia over 24 hrs will be studied in the two groups. |
| Intervention |
Ultrasound guided Bilateral Tranversus Abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy patients |
76 Patients will be randomly divided into two groups of 38 each. Bilateral subcostal tranversus abdominis plane block will be performed under ultrasound guidance in each patient as a component of multimodal analgesia in each patient prior to extubation. Group 1 will receive 20ml 0.25%levobupivacaine with 1 ml Normal saline on each side. Group2 will receive 0.25% levobupivacaine with 4mg dexamethasone on each side.The neurofascial plane between the rectus abdominis muscle and transversus abdominis muscle will be identified and drug will be injected after confirming correct needle placement under ultrasound guidance. Postoperatively the quality of analgesia between two groups would be compared using NRS at rest and on coughing.Postoperative rescue opioids and adverse effects will also be compared between the two groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiologists (ASA)
physical status І and ІІ
2.Age 18 to 60 yrs.
3.Body mass index < 30 kg/m2
4.Patients scheduled to undergo elective
laparoscopic cholecystectomy under general
anaesthesia lasting up to 120 minutes of
duration.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with known hypersensitivity or allergy to local anaesthetics
3. ASA physical status ІІІ and ІV
4. Patients with Diabetes Mellitus
5. Immunocompromised patients
6. Local site infection
7. Bleeding diathesis
8. Patients with chronic pain conditions
9. Patients with opioid addiction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric rating scale (NRS) pain scores on coughing postoperatively. |
Numeric rating scale (NRS) on coughing at 2,4, 6, 12 and 24 hrs postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric rating scale (NRS) pain scores at rest, Time to first rescue analgesic, Total postoperative opioid consumption during 24 hrs, Postoperative nausea, vomiting and sedation. |
0, 2, 4, 6, 12 and 24 hrs postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
10/05/2019 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Our study intends to compare the postoperative analgesia in patients undergoing laparoscopic cholecystectomy using ultrasound guided bilateral subcostal transversus abdominis plane block with 0.25% levobupivacaine vs 0.25% levobupivacaine with dexamethasone. Our study aims to comapare the two groups in terms of quality, duration of analgesia and adverse effects if any postoperatively. |