| CTRI Number |
CTRI/2024/11/077503 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare two doses of Dexmedetomidine as an additive in injection Ropivacaine for an analgesic abdominal block for hernia surgery |
|
Scientific Title of Study
|
Comparison Of 0.25mcg/kg Dexmedetomidine and 0.5mcg/kg Dexmedetomidine as an Adjuvant to 0.2% Ropivacaine For Postoperative Analgesia in Ultrasound Guided Transversus Abdominis Plane Block for Open Inguinal Hernia Repair – A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalyani Thote |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9922960681 |
| Fax |
|
| Email |
kalyanithote94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Bhure |
| Designation |
Professor and HOD, Department of Anaesthesiology |
| Affiliation |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822563121 |
| Fax |
|
| Email |
anjali_bhure@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalyani Thote |
| Designation |
Junior Resident |
| Affiliation |
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9922960681 |
| Fax |
|
| Email |
kalyanithote94@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur, 440019 |
| 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 |
| Dr Kalyani Thote |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur, 440019
Nagpur
MAHARASHTRA |
9922960681
kalyanithote94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25mcg/kg Dexmedetomidine in 2ml NS and 18 ml of 0.2% Ropivacaine |
Ultrasound Guided Transversus Abdominus Plane Block using 0.25mcg/kg Dexmedetomidine in 2ml NS and 18 ml of 0.2% Ropivacaine in patients undergoing inguinal hernia surgery |
| Comparator Agent |
0.5mcg/kg Dexmedetomidine in 2 ml NS and 18 ml of 0.2% Ropivacaine |
Ultrasound Guided Transversus Abdominus Plane Block 0.5mcg/kg Dexmedetomidine in 2 ml NS and 18 ml of 0.2% Ropivacaine in patients undergoing inguinal hernia surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient scheduled for elective open Inguinal hernia surgery under subarachnoid block.
2) American society of Anesthesiologist (ASA) physical status I, II.
3) Patient giving consent for study.
5) BMI less than 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1) Bleeding disorders.
2) History of cardiac, renal, respiratory or hepatic disease.
3) Allergy to study drugs.
4) Patients consuming adrenoceptors agonist or antagonist. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of dexmedetomidine 0.25mcg/kg and 0.5 mcg/kg as
an adjuvant to 0.2% ropivacaine for post operative analgesia in
ultrasound guided transversus abdominis plane block in open
inguinal hernia repair |
1) Numerical rating scale (NRS) for pain assessment at 0,1,2,4,6,12 and 24 hours after surgery.
2) Time of requirement of first rescue analgesia in 24 hrs.
3) Total analgesic doses required in first 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare side effects of dexmedetomidine 0.25mcg/kg and
0.5mcg/kg as an adjuvant to 0.2% ropivacaine in ultrasound guided
transversus abdominis plane block in open inguinal hernia repair
with respect to :
1) Sedation
2) Hemodynamic instability |
For 24 hrs after Surgery |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
• Regional anesthetic offers site-specific, long-lasting, and effective anesthesia. Transversus abdominis plane block is a peripheral nerve block that blocks feeling in the parietal peritoneum and the anterior and lateral abdominal walls.. • Transversus abdominis plane contains intercostal nerves (T7-T11), subcostal nerves(T12), iliohypogastric and ilioinguinal nerves(L1). •Due to its accessibility, dependability, and safety, it is one of the most often used truncal blocks for post-operative analgesia in lower abdominal procedures. • The amount of local anesthetic used, the frequency of vascular punctures, and the block performance time are all decreased using ultrasound guiding. • Chronic or persistent postoperative pain results from acute postoperative pain that is not well managed. Between 5% and 35% of hernia repair cases involve chronic pain (3). • The addition of adjuvant increases the effectiveness of local anesthetics by decreasing the duration of onset of action, prolonging the duration of action, decreasing pain intensity, reducing consumption of systemic opioids, and reducing systemic side effects. • Ropivacaine, an enantiomer of buprevacaine, is a long-acting amide that is less likely to penetrate large myelinated motor fibers, resulting in a safer cardiac profile used for peripheral nerve block. • Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist with analgesic and sedative properties. It prolongs the duration of both sensory and motor blockade induced by local anaesthetics when administrated by epidural, caudal, or spinal route. • There are certain studies using 1mcg/kg or 0.5mcg/kg of dexmedetomidine as an adjuvant to local anaesthetic agent in TAP block, therefore in order to observe the analgesic efficacy and side effects of using further lower dose of dexmedetomidine, 0.25mcg/kg will be taken. • Hence, the aim of this study is to compare 0.25mcg/kg Dexmedetomidine and 0.5mcg/kg dexmedetomidine as an adjuvant to 0.2% ropivacaine in ultrasound guided transversus abdominis plane block for post operative analgesia in open inguinal hernia repair. |