| CTRI Number |
CTRI/2021/01/030498 [Registered on: 15/01/2021] Trial Registered Prospectively |
| Last Modified On: |
14/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ULTRASOUND GUIDED QUADRATUS LUMBORUM BLOCK VERSUS TRANSVERSUS ABDOMINIS PLANE BLOCK FOR POST OPERATIVE PAIN MANAGEMENT IN LAPROSCOPIC INGUINAL HERNIA AND APPENDICECTOMY USING ROPIVACAINE AND DEXMEDETOMIDINE |
|
Scientific Title of Study
|
ULTRASOUND GUIDED QUADRATUS LUMBORUM BLOCK VERSUS TRANSVERSUS ABDOMINIS PLANE BLOCK FOR LAPROSCOPIC INGUINAL HERNIA REPAIR AND APPENDICECTOMY USING ROPIVACAINE WITH DEXMEDETOMIDINE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VAGHELA SHASHIRAJ |
| Designation |
JUNIOR RESIDENT, M.D. ANAESTHESILOGY |
| Affiliation |
king george medical uiversity |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, K.G.M.U, LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9758809126 |
| Fax |
|
| Email |
vaghela140shashi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MPARVEZ KHAN |
| Designation |
PROFESSOR, M.D. ANAESTHESILOGY |
| Affiliation |
king george medical uiversity |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, K.G.M.U, LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839070724 |
| Fax |
|
| Email |
mpk_786@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VAGHELA SHASHIRAJ |
| Designation |
JUNIOR RESIDENT, M.D. ANAESTHESILOGY |
| Affiliation |
king george medical uiversity |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, K.G.M.U, LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9758809126 |
| Fax |
|
| Email |
vaghela140shashi@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, KING GEORGE MEDICAL UNIVERSITY,LUCKNOW, U.P |
|
|
Primary Sponsor
|
| Name |
DR VAGHELA SHASHIRAJ |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,K.G.M.U, LUCKNOW |
| 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 MPARVEZ KHAN |
KING GEORGE MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIOLOGY,KING GEORGE MEDICAL COLLEGE, LUCKNOW
Lucknow
UTTAR PRADESH |
9839070724
mpk_786@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGE MEDICAL COLLEGE,LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ULTRASOUND GUIDED QUADRATUS LUMBORUM BLOCK FOR LAPROSCOPIC INGUINAL HERNIA REPAIR AND APPENDICECTOMY USING ROPIVACAINE WITH DEXMEDETOMIDINE |
ULTRASOUND GUIDED QUADRATUS LUMBORUM BLOCK
ROUTE: INTRAMUSCULER
DOSE: 0.5%ROPIVACAINE 20ml with DEXMEDETOMIDINE 0.05MCG/KG
DURATION: 24 HOURS POST OPERATIVE TIME |
| Comparator Agent |
Comparision between qudratus lumborum block and transversus abdominis block |
ULTRASOUND GUIDED QUADRATUS LUMBORUM BLOCK VERSUS TRANSVERSUS ABDOMINIS PLANE BLOCK FOR LAPROSCOPIC INGUINAL HERNIA REPAIR AND APPENDICECTOMY USING ROPIVACAINE WITH DEXMEDETOMIDINE |
| Intervention |
ULTRASOUND GUIDED TRANSVERSE ABDOMINIS BLOCK FOR LAPROSCOPIC INGUINAL HERNIA REPAIR AND APPEDICECTOMY USING ROPIVACAINE AND DEXMEDETOMIDINE |
ULTRASOUND GUIDED TRANSVERSE ABDOMINIS BLOCK
ROUTE: INTRAMUSCULER
DOSE: 0.5%ROPIVACAINE 20ml with DEXMEDETOMIDINE 0.5MCG/KG
DURATION: 24 HOURS POST OPERATIVE TIME |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I &II.
Aged between 20–50years.
Patients for Laproscopic Inguinal Hernia
repair and Appendicectomy.
Patient giving written consent.
|
|
| ExclusionCriteria |
| Details |
ASA grade 3 and above.
Infection at the site of injection.
Allergy to study drug
Localized malignant tumour
Heart block
Patients with coagulation disorder.
Difficulty in communication with patient.
Pregnant and Lactating patients.
Obese patient.(BMI>30)
Technically difficult block.
Patient on chronic analgesic medication.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the quality and duration of postoperative analgesia. |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Alleviating pain during intraoperative and postoperative period is of major concern to anaesthesiologists. Infraumblical abdominal surgeries has been associated with severe pain and hence morbidity and mortality. To relieve this pain lots of modalities in the form of systemic analgesia, epidural analgesia and various therapies have been employed. Off late there is a growing inclination towards regional block. These blocks offer less systemic side effects with profound analgesia. Quadratus Lumborum(QL) and Transverses Abdominis plane block(TAP) has been found to be quite effective with respect to pain relief for infraumblical abdominal surgeries. Quadratus Lumborum and Transversus Abdominis plane block are new rapidly expanding regional anaesthesia technique that provide analgesia following lower abdominal surgeries.
|