| CTRI Number |
CTRI/2024/06/068266 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison between transverse abdominal block and quadratus lumborum block in patients undergoing laparoscopic intraperitoneal onlay mesh repair in umbilical hernia in adults. |
|
Scientific Title of Study
|
A Comparative evaluation between Transverse abdominal plane block versus Quadratus lumborum block in intraperitoneal onlay laparoscopic umbilical hernia mesh repair in adults:A Prospective randomised controlled study. |
| 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 Alieshia Siangshai |
| Designation |
Post Graduate in Deaprtment of Anaesthesia |
| Affiliation |
Raja Rajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore Road, Kambipura, Bangalore Karnataka 560074.
Bangalore
KARNATAKA
560074
India |
| Phone |
7337875748 |
| Fax |
|
| Email |
alieshiasiangshai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik G S |
| Designation |
Professor |
| Affiliation |
Raja Rajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore Road, Kambipura, Bangalore Karnataka 560074.
Bangalore
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthik G S |
| Designation |
Professor |
| Affiliation |
Raja Rajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore Road, Kambipura, Bangalore Karnataka 560074.
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, 2nd floor, Rajarajeswari Medical College and Hospital, Bangalore-560074 |
|
|
Primary Sponsor
|
| Name |
Dr Alieshia Siangshai |
| Address |
Department of Anaesthesiology,Raja Rajeswari Medical College and Hospital, Mysore Road, Kambipura, Bangalore Karnataka-560074 India |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alieshia Siangshai |
Raja Rajeswari Medical College and Hospital |
Department of Anaesthesia, Raja Rajeswari Medical College an Hospital, Mysore Road, Kambipura,Bangalore, Karnataka 560074- India
Bangalore
KARNATAKA |
7337875748
alieshiasiangshai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Quadratus lumborum block in intraperitoneal onlay Laparoscopic umbilical hernia mesh repair in adults. |
Patients undergoing intra peritoneal onlay laparoscopic umbilical hernia mesh repair will be divided into Group QL. Group QL will receive QL block with Injection Levobupivacaine 0.25% 20ml on each side.Time needed to administer the first rescue analgesia in the postoperative period is compared between two groups. |
| Intervention |
Transverse abdominis plane block in intraperitoneal onlay laproscopic umbilical hernia mesh repair in adults. |
Patients undergoing intra peritoneal onlay laparoscopic umbilical hernia mesh repair will be divided into Group TAP. Group TAP will receive TAP block with Injection Levobupivacaine 0.25% 20ml on each side.Time needed to administer the first rescue analgesia in the postoperative period is compared between two groups. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade 1 and 2 patients.
2. Patients undergoing umbilical hernia repair under general anaesthesia. |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia using Injection Levobupivacaine 0.25% 20ml on each side by TAP block and QL block in patients undergoing intraperitoneal onlay laparascopic umbilical hernia repair in adults. |
To compare the duration of postoperative analgesia using Injection Levobupivacaine 0.25% 20ml on each side by TAP block and QL block in patients undergoing intraperitoneal onlay laparascopic umbilical hernia repair in adults at 2hours,4 hours, 8 hours,12 hours and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic parameters like NIBP,HR, BP and Spo2 for 24 hours postoperatively.
2.Post operative Visual Analogue Scale pain score.
3. Time of rescue analgesia.
4. Adverse effects. |
First 24 hours monitoring. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/06/2024 |
| 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="10"
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
|
Postoperative analgesia is important after surgery to avoid various complications such as venous thromboembolism, respiratory complications and prolonged hospital stay.1. The Transverse abdominis plane (TAP) block and Quadratus Lumborum block is increasingly playing a role in postoperative analgesia for abdominal surgeries.2. Quadratus Lumborum block produces a broad distribution of local anaesthetic resulting in large area of sensory inhibition. 3. It decreases opioids consumption and analgesic requirement with the benefits of reducing opioids side effects especially nausea, vomiting and also aids early ambulation and reduces the number of stay in the hospital. 4. Various trials have been demonstrated the efficacy of Quadratus Lumborum block and Transverse Abdominis Plane block as a multimodal analgesia after laparoscopic hernia repair via ultra sound guided. In our study effort has been made to compare duration of post operative analgesia between Transverse Abdominis plane block ans Quadratus Lumborum block using injection Levobupivaciane 0.25% 20ml on each side on patients undergoing laparoscopic intraperitoneal onlay mesh hernia repair.
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