| CTRI Number |
CTRI/2020/07/026566 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
08/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Comparing two different ultrasound guided nerve block for post operative pain relief in inguinal hernia surgeries |
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Scientific Title of Study
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COMPARISON OF ULTRASOUND GUIDED LUMBAR ERECTOR SPINAE BLOCK WITH TRANSVERSUS ABDOMINIS PLANE BLOCK FOR POST-OPERATIVE ANALGESIA IN INGUINAL HERNIA REPAIR: A RANDOMISED CONTROL STUDY
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen R Nandaragi |
| Designation |
1st year PG student |
| Affiliation |
S Nijalingappa Medical College and Research Institute, HSK Hospital, Bagalkot |
| Address |
Department of Anaesthesia,
S N Medical college,
Bagalkot.
Bagalkot KARNATAKA 587102 India |
| Phone |
9916588994 |
| Fax |
|
| Email |
nandaraginaveenr@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Ramesh Koppal |
| Designation |
Professor |
| Affiliation |
S Nijalingappa Medical College and Research Institute, HSK Hospital, Bagalkot |
| Address |
Department of Anaesthesia,
S N Medical college,
Bagalkot. B 24, SN Medical college staff quarters,Bagalkot 587102 Bagalkot KARNATAKA 587102 India |
| Phone |
9845504515 |
| Fax |
|
| Email |
rameshkoppaldr@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Naveen R Nandaragi |
| Designation |
1st year PG student |
| Affiliation |
S Nijalingappa Medical College and Research Institute, HSK Hospital, Bagalkot |
| Address |
Department of Anaesthesia,
S N Medical college,
Bagalkot.
KARNATAKA 587102 India |
| Phone |
9916588994 |
| Fax |
|
| Email |
nandaraginaveenr@gmail.com |
|
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Source of Monetary or Material Support
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| S N Medical college and HSK hospital,Bagalkot |
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Primary Sponsor
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| Name |
S N Medical college and HSK hospital |
| Address |
Navanagar,Bagalkot |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Naveen R Nandaragi |
S N Medical college and HSK Hospital |
Department of Anaesthesia, 1st floor, Major OT complex Bagalkot KARNATAKA |
9916588994
nandaraginaveenr@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC-INSTITUTE ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Erector spinae,TAP block |
Comparing efficacy of post op analgesia of these blocks 1st post op day |
| Intervention |
Erector spinae,TAP block |
Ultrasound guided for post op analgesia |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I-II Patients.
2. Patients undergoing elective unilateral inguinal
hernia repair. |
|
| ExclusionCriteria |
| Details |
1. Refusal at enrolment.
2. Patients with coagulation system disorders.
3. Patients with raised intra cranial tension.
4. Patients with fixed cardiac output states.
5. Patients with hepatic or renal failure.
6. Chronic use of opioids or corticosteroids.
7. Patients allergic to the drugs/ Local
anaesthetics to be used for the study
8. Infection at injection site
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| Duration of post operative analgesia will be assessed after giving ultrasound guided block |
24 hours after the block |
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Secondary Outcome
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| Outcome |
TimePoints |
| None |
not applicable |
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Target Sample Size
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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" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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23/07/2020 |
| 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 |
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Estimated Duration of Trial
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Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Tulgar S et al,3conducted a study on 60 persons undergoing hip or proximal femur surgeries, aging between 18-65 years, belonging toASA grade I-III.Three groups were present in the study, namely Lumbar Erector Spinae Block (L-ESPB)group, Transmuscular Quadratus Lumborum Block (QLB-T) group and the Control group in which no block was performed. Blocks were given for better post-operative analgesia. Each group consisted of 20 patients each.Pain intensity between groups was compared using Numeric Rating Scores (NRS). The NRS scores at 1st, 3rd and 6th hours and the number of patients required rescue analgesic in 24 h were significantly higher in the control group compared to both block groups. |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The benefits of good postoperative analgesia include reduction in the postoperative stress response and morbidity, better patient satisfaction, early ambulation, early discharge from post-operative care unit, early discharge in day care surgeries and improved outcome. And also adequate post-operative analgesia will reduce overall complications, including respiratory. Most of the patients coming for inguinal hernia repair are in elderly age group, who deserve adequate post-operative analgesia. Because in these age group often they have other co morbidities like diabetes mellitus, hypertension. Inguinal hernia repair can lead to significant post-operative pain. Non opioid analgesia techniques are especially important in aging populations when co-morbidities are considered. Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute and postoperative pain. In this ultrasound-guided (USG) technique, local anesthetic is applied between the erector spinae muscle and the transverse process of the vertebra leading to spread of local anaesthetic cephalad, caudally and also through the paravertebral space. The Transversus abdominis plane (TAP) block is an alternate, easy to perform, and an effectiveperipheral abdominal field block that blocks the ilioinguinal, hypogastric and lower intercostal(T7–T11) nerves. TAP block is a novel technique for blocking the abdominal wall neural afferents via the lumbar triangle of Petit. This study is going to establish Effectiveness of LumbarErector Spinae Block (L-ESPB) and Transversus Abdominis Plane (TAP) blocks in post-operative analgesia after inguinal hernia repair, which will be going to help us practice good multimodal analgesia in the post-operative period. |