| CTRI Number |
CTRI/2019/04/018825 [Registered on: 29/04/2019] Trial Registered Prospectively |
| Last Modified On: |
24/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare efficacy of two different abdominal plane blocks for providing postoperative pain relief after inguinal hernia repair surgeries. |
|
Scientific Title of Study
|
Comparing the postoperative analgesic efficacy of Quadratus Lumborum block vs Transverse Abdominis plane block in patients undergoing elective unilateral open inguinal hernia repair surgeries:a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun S |
| Designation |
Assistant professor |
| Affiliation |
Dr.somervell memorial C.S.I medical college |
| Address |
Dr.somervell memorial C.S.I medical college,
Karakonam.
Thiruvananthapuram.
India.
Pin-695504
Thiruvananthapuram
KERALA
Karakonam.
Thiruvananthapuram.
KERALA.
India
Pin-695504
Thiruvananthapuram
KERALA
695504
India |
| Phone |
9894555023 |
| Fax |
|
| Email |
arunsam85@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun S |
| Designation |
Assistant professor |
| Affiliation |
Dr.somervell memorial C.S.I medical college |
| Address |
Dr.somervell memorial C.S.I medical college,
Karakonam.
Thiruvananthapuram
KERALA
India Pin-695504
Karakonam.
Thiruvananthapuram
KERALA.
India
Pin-695504
Thiruvananthapuram
KERALA
695504
India |
| Phone |
9894555023 |
| Fax |
|
| Email |
arunsam85@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun S |
| Designation |
Assistant professor |
| Affiliation |
Dr.somervell memorial C.S.I medical college |
| Address |
Dr.somervell memorial C.S.I medical college,
Karakonam.
Thiruvananthapuram.
KERALA.
India Pin-695504
Karakonam.
Thiruvananthapuram
KERALA
India Pin-695504
Thiruvananthapuram
KERALA
695504
India |
| Phone |
9894555023 |
| Fax |
|
| Email |
arunsam85@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology.
Dr.Somervell memorial C.S.I Medical College and hospital.karakonam.
THIRUVANANTHAPURAM |
|
|
Primary Sponsor
|
| Name |
DrSMCSImedical college |
| Address |
Dr.S.M.C.S.I.medical college, Karakonam, Thiruvananthapuram India. Pin-695504 |
| 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 |
| ARUN S |
Dr.sOMERVELL Memorial C.S.I Medical college and hospital |
van knowles complex,second floor,room number 228,
Karakonam Thiruvananthapuram India Pin-695504
KERALA
Thiruvananthapuram
KERALA |
9894555023
arunsam85@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution human ethics committee,Dr.S.M.C.S.I medical college |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus lumborum block |
quadratus lumborum block in which local anesthetic (20ml of 0.25% ropivacaine) will be injected under usg guidance between quadratus lumborum block and psoas major muscles. |
| Comparator Agent |
Transverse Abdominis plane Block |
local anesthetic (20 ml of 0.25% ropivacaine) injected in between internal oblique and transverse abdominis muscle of abdomen under USG guidance. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 OR 2
Elective hernia repair
BMI between 20-35 kg/sqm |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergic to local anesthetics
Coagulation abnormality
Psychiatric illness
Local skin infection
BMI >35kg/sqm
ASA 4 or greater
patients with recurrent or complicated hernia
|
|
|
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia. |
Duration of postoperative analgesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative Numerical rating Pain scores(NRS) at 0,1,2,3,4,5,6,8,12,24 hours and the mean postoperative NRS score.
|
Monitored for 24 hours after block performance |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We will compare the quadratus lumborum (QL) block and transversus abdominis plane (TAP) block in unilateral open inguinal hernia repair surgeries.TAP block mainly anaesthesizes the somatic nerves supplying the anterior abdominal wall.The QL block spread to paravertebral space and can be useful for both somatic and visceral pain. so we hypothesize that QL block is better than TAP block in inguinal hernia repair surgeries.we will compare the analgesic efficacy by estimating the duration of analgesia in two groups .In case of pain the patients will be supplemented with inj.tramadol. |