| CTRI Number |
CTRI/2025/07/091450 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to asses duration of post operative analgesia by USG Guided Transversus abdominis plane block and Anterior Quadratus Lumborum block in male patients undergoing Inguinal hernia repair surgery, under Spinal Anaesthesia |
|
Scientific Title of Study
|
COMPARISON OF THE DURATION OF POST OPERATIVE ANALGESIA BY ULTRASOUND GUIDED TRANSVERSE ABDOMINIS PLANE BLOCK AND ANTERIOR QUADRATUS LUMBORUM BLOCK IN PATIENTS UNDERGOING INGUINAL HERNIA REPAIR UNDER SUB ARACHNOID BLOCK: DOUBLE BLIND, RANDOMISED CONTROL TRIAL |
| 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 Pramod |
| Designation |
Junior Resident |
| Affiliation |
Ballari Medical College and Research Centre |
| Address |
Dr. Pramod
Junior Resident
Department of Anaesthesiology
Major OT complex
Ballari Medical College And Research Centre
Cantonment area
Ballari
Bellary
KARNATAKA
580104
India |
| Phone |
9480561036 |
| Fax |
|
| Email |
pramodmk927@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parimala |
| Designation |
Professor |
| Affiliation |
Ballari Medical College And Research Centre |
| Address |
Dr. Parimala
Professor
Department of Anaesthesiology
Major OT complex
Ballari Medical College And Research Centre
Cantonment Area
Ballari
Bellary
KARNATAKA
580104
India |
| Phone |
9742530338 |
| Fax |
|
| Email |
dr.parimaladu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parimala |
| Designation |
Professor |
| Affiliation |
Ballari Medical College And Research Centre |
| Address |
Dr. Parimala
Professor
Department of Anaesthesiology
Major OT complex
Ballari Medical College And Research Centre
Cantonment Area
Ballari
KARNATAKA
580104
India |
| Phone |
9742530338 |
| Fax |
|
| Email |
dr.parimaladu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ballari Medical College And Research Centre
Cantonment Area
Ballari
Karnataka- 583104
|
|
|
Primary Sponsor
|
| Name |
Dr Pramod |
| Address |
Dr Pramod
Junior Resident
Department of Anaesthesiology
Major OT Complex
Ballari Medical College And Research Centre
Cantonment Area
Ballari
Karnataka- 583104
|
| 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 Pramod |
Ballari Medical College And Research Centre |
Department of Anaesthesiology,
Major OT Complex,
Ballari Medical College And Research Centre,
Cantonment Area,
Ballari
Karnataka- 583104
Bellary
KARNATAKA |
9480561036
pramodmk927@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ballari Medical College and Research Centre, Ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anterior Quadratus lumborum block |
Anterior Quadratus lumborum block with 20ml Inj.Ropivacane 0.25% + inj. Dexmedetomidine 0.5 mcg /kg given and assed 24hrs for duration of analgesia |
| Comparator Agent |
Transverse abdominis plane block |
Transverse abdominis plane block with 20ml Inj.Ropivacane 0.25% + inj. Dexmedetomidine 0.5 mcg /kg given and assed 24hrs for duration of analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1) Patient posted for elective unilateral open inguinal hernioplasty
2) ASA 1 and 2
3) Male gender
4) Age 18-60 years |
|
| ExclusionCriteria |
| Details |
1) patient not giving consent to participate in study
2) Patient with allergic to medication use
3) Contraindication to spinal anaesthesia.
4) Patient with cardiovascular, neurological, respiratory, renal disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Post operative Analgesia |
Post operative every 15 min in 1st hour and every 30 min till 1st dose of rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NRS Score at Rest and on coughing till rescue analgesia
|
24hrs |
| Objective pain assessment of pain using pin prick test |
every 15 min in 1st hour and every 30min till 1st dose of rescue analgesia |
| Total dose of additional analgesic request |
24hrs |
| Level of sedation using RAMSAY SEDATION SCORE |
24hrs |
| Time of ambulation |
24hrs |
| Level of patient satisfaction using LIKERT SCORE |
24hrs |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pramodmk927@gmail.com].
- For how long will this data be available start date provided 30-08-2025 and end date provided 11-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomised, double blind, parallel group, single centre trial comparing the duration of post operative analgesia in 2 group, Group A Transverse abdominis plane block and Group B in Quadratus lumborum block under Ultrasound sound guided in 18 yr to 60yr old male patients undergoing Inguinal hernia repair surgery under spinal anaesthesia. Study will be conducted with primary outcome of determining time of 1st dose of rescue analgesia and secondary outcome is assessing NRS score at rest and on cough, objective pain assessment, total doses of additional analgesia received in 24hrs, level of sedation, time of ambulation, level of patient satisfaction |