| CTRI Number |
CTRI/2018/05/013765 [Registered on: 08/05/2018] Trial Registered Prospectively |
| Last Modified On: |
08/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two methods of pain management following inguinal hernia repair. |
|
Scientific Title of Study
|
Comparison of ultrasound guided transversalis fascia plane block versus transversus abdominis plane block for postoperative analgesia following inguinal hernia surgery-a prospective randomised clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARJUN BK |
| Designation |
SENIOR RESIDENT |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY. KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, VV PURAM , KR ROAD, BENGALURU
205/4 1ST MAIN 12TH CROSS, BAPUJINAGAR, BENGALURU 560026
Bangalore
KARNATAKA
560004
India |
| Phone |
9972802569 |
| Fax |
|
| Email |
arjun.bg88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARJUN BK |
| Designation |
SENIOR RESIDENT |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY. KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, VV PURAM , KR ROAD, BENGALURU
205/4 1ST MAIN 12TH CROSS, BAPUJINAGAR, BENGALURU 560026
KARNATAKA
560004
India |
| Phone |
9972802569 |
| Fax |
|
| Email |
arjun.bg88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARJUN BK |
| Designation |
SENIOR RESIDENT |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY. KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, VV PURAM , KR ROAD, BENGALURU
205/4 1ST MAIN 12TH CROSS, BAPUJINAGAR, BENGALURU 560026
KARNATAKA
560004
India |
| Phone |
9972802569 |
| Fax |
|
| Email |
arjun.bg88@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARJUN B K
Department of anaesthesiology, KIMS, VV puram, KR road, Bengaluru 560004 |
|
|
Primary Sponsor
|
| Name |
ARJUN B K |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KIMS, BENGALURU |
| Type of Sponsor |
Private medical college |
|
|
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 |
| ARJUN B K |
Kempegowda institute of medical sciences |
Operation room, A block, 4th floor,Department of Anaesthesiology, VV puram, KR road,Bengaluru
Bangalore
KARNATAKA |
9972802569
arjun.bg88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS POSTED FOR ELECTIVE UNILATERAL INGUINAL HERNIA REPAIR, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1 |
ULTRASOUND GUIDED TRANSVERSALIS FASCIA PLANE BLOCK |
| Comparator Agent |
GROUP 2 |
ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective unilateral open inguinal hernia repair
2. Aged between 18 and 60 years of age
3. American Society of Anesthesiologists (ASA) class 1 and 2
|
|
| ExclusionCriteria |
| Details |
1. Allergy to local anaesthetic
2. BMI>35kg/m2
3. Chronic abuse of analgesic medications
4. Bleeding disorder, pregnancy and infection near the procedure area
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TIME FOR REQUEST OF FIRST RESCUE ANALGESIA |
TIME FOR REQUEST OF FIRST RESCUE ANALGESIA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. PATIENT SATISFACTION
2.TOTAL ANALGESIC CONSUMPTION IN 24HOURS
3. COMPLICATIONS |
UPTO 24HOURS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/05/2018 |
| 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
|
1..Lee THW, Barrington MJ, Tran TM, Wong D, Hebbard PD. Comparison of extent of sensory block following posterior and subcostal approaches toultrasound-guided transversus abdominis plane block. Anaesth Intensive care. 2010;38:452–460.
3.Borglum J, Christensen AF, Hoegberg LCG, et al. Bilateral-dual transversus abdominis plane (BD-TAP) block or thoracic paravertebral block (TPVB)? Distribution patterns, dermatomal anaesthesia and pharmacokinetics. Reg Anesth Pain Med. 2012;1:E137–E139.
4.Peter D Hebbard, Fanzca. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anesth (2009) 56:618–620.
5.Petersen PL, Mathiesen O, Stjernholm P, et al. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013;30:415–421.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Inguinal hernia repair is a common surgical procedure with reported upto 54% patients developing chronic pain. Thus, effective postoperative pain management is essential to prevent development of chronic pain.Several methods have been described for postoperative analgesia following inguinal hernia. our study aims at comparing novel ultrasound guided transversalis fascia plane block with transversus abdominis plane block for postoperative analgesia following elective unilateral inguinal hernia repair with respect to duration of analgesia or first request of rescue analgesia, patient satisfaction and any complications. |