| CTRI Number |
CTRI/2019/10/021766 [Registered on: 23/10/2019] Trial Registered Prospectively |
| Last Modified On: |
22/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF TWO NERVE BLOCKS FOR HERNIA SURGERY FOR POSTOPERATIVE PAIN RELIEF |
|
Scientific Title of Study
|
EFFECTIVENESS OF ERECTOR SPINAE PLANE BLOCK AND TRANSVERSUS ABDOMINIS PLANE BLOCK IN INGUINAL HERNIA REPAIR FOR POSTOPERATIVE ANALGESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAJNA S |
| Designation |
POST GRADUATE |
| Affiliation |
KANYAKUMARI GOVERNMENT MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM
KANNIYAKUMARI
TAMIL NADU
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9400332750 |
| Fax |
|
| Email |
sajnasn18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR EDWARD JOHNSON |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
KANYAKUMARI GOVERNMENT MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM
KANNIYAKUMARI
TAMIL NADU
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9443392974 |
| Fax |
|
| Email |
edwardjohnson2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAJNA S |
| Designation |
POST GRADUATE |
| Affiliation |
KANYAKUMARI GOVERNMENT MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM
KANNIYAKUMARI
TAMIL NADU
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9400332750 |
| Fax |
|
| Email |
sajnasn18@gmail.com |
|
|
Source of Monetary or Material Support
|
| HOD DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM NAGERCOIL
|
|
|
Primary Sponsor
|
| Name |
SAJNA S |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM |
| 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 |
| SAJNA S |
KANYAKUMARI GOVERNMENT MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY
ASARIPALLAM
KANNIYAKUMARI
TAMIL NADU
Kanniyakumari
TAMIL NADU |
9400332750
sajnasn18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KANYAKUMARI GOVERNMENT 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 |
ERECTOR SPINAE PLANE BLOCK |
INJECTION BUPIVACAINE 20ML 0.25% BELOW ERECTOR SPINAE MUSCLE SUPERFICIAL TO TIP OF T9 TRANSVERSE PROCESS |
| Comparator Agent |
TRANSVERSUS ABDOMINIS PLANE BLOCK |
INJECTION BUPIVACAINE 20ML 0.25% BETWEEN TRANSVERSUS ABDOMINIS AND INTERNAL OBLIQUE MUSCLE AT MIDAXILLARY LINE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
WRITTEN INFORMED CONSENT
ASA PS I AND II |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
ASA PS III AND IV
KNOWN ALLERGY TO LOCAL ANAESTHETIC AGENTS
BLEEDING DIATHESIS OR USE OF ANTICOAGULANTS
SEVERE KIDNEY OR LIVER DISEASE
PSYCHIATRIC DISORDER
MORBID OBESITY |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF ANALGESIA |
24HRS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
QUALITY OF ANALGESIA NRS SCORE
POSTOPERATIVE 24HRS ANALGESIC REQUIREMENT
COMPLICATIONS IF ANY |
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)
|
05/11/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients undergoing hernioplasty suffer significant postoperative pain and multimodal analgesia is used to control postoperative pain.Ultrasound guided TAP block and ESP block applied to lower thoracic region was reported to provide extensive, potent analgesia in unilateral inguinal hernia surgeries by acting on both dorsal and ventral branches of thoracic spinal nerves. Hence the aim of study is to compare the effectiveness of Erector spinae plane block and Transversus abdominis plane block in inguinal hernia repair done under spinal anaesthesia for postoperative analgesia. Primary outcome is duration of analgesia which is the time interval between the performance of the block and time of first analgesic request and secondary outcome is the quality of analgesia - NRS score, postoperative analgesic requirement for a period of 24 hrs and complications if any. Erector spinae block is expected to have prolonged and effective postoperative analgesia for unilateral inguinal hernia repair when compared to transversus abdominis plane block. |