| CTRI Number |
CTRI/2024/12/078420 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| 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 clinical trial comparing two combinations of drugs in ultrasound guided transversus abdominis plane block to determine the efficacy for post operative pain relief in patients undergoing Hysterectomy surgery. |
|
Scientific Title of Study
|
Comparison of Dexamethasone and Magnesium sulphate as adjuvants to Ropivacaine in ultrasound guided transversus abdominis plane block for post operative analgesia in patients undergoing Total Abdominal Hysterectomy: 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 Mrunal Bharsakale |
| Designation |
Junior Resident |
| Affiliation |
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. |
| Address |
Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills
Nagpur MAHARASHTRA 440019 India |
| Phone |
7798517567 |
| Fax |
|
| Email |
mbharsakale@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anjali Bhure |
| Designation |
Professor and Head, Department of Anaesthesiology |
| Affiliation |
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. |
| Address |
Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9822563121 |
| Fax |
|
| Email |
anjali_bhure@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Mrunal Bharsakale |
| Designation |
Junior Resident |
| Affiliation |
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. |
| Address |
Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur.
Nagpur MAHARASHTRA 440019 India |
| Phone |
7798517567 |
| Fax |
|
| Email |
anjali_bhure@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 440019 |
|
|
Primary Sponsor
|
| Name |
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. |
| Address |
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 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 Mrunal Bharsakale |
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. |
Department of Anaesthesia, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 440019 Nagpur MAHARASHTRA |
7798517567
mbharsakale@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 |
Dexamethasone with Ropivacaine |
8mg Dexamethasone and 15 ml of 0.20% Ropivacaine on each side for Transversus Abdominis Plane Block |
| Comparator Agent |
Magnesium Sulphate with Ropivacaine |
150mg Magnesium sulphate and 15 ml of 0.20% Ropivacaine on each side for Transversus Abdominis Plane Block |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients scheduled for elective Total Abdominal Hysterectomy surgery under subarachnoid block.
2) American Society of Anaesthesiologists (ASA) physical status 1 and 2.
3) Patients giving consent for study.
4) BMI less than 30 kg/m3 |
|
| ExclusionCriteria |
| Details |
1) Bleeding disorders.
2) History of cardiac, renal, respiratory or hepatic disease.
3) Allergy to study drugs.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare post operative analgesia of Dexamethasone and Magnesium sulphate as an adjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block in Total Abdominal Hysterectomy in terms of
1) Numerical rating scale (NRS) for pain assessment.
2) Time of requirement of first rescue analgesia.
3) Total analgesic doses required in first 24 hours |
1)Post-operative pain assessment will be done by Numerical Rating score (NRS) at 0,1,2,4,6,12 and 24 hours after surgery.
2) Time of requirement of first rescue analgesia.
3) Total analgesic doses required in first 24 hours.
4) Total number of rescue analgesia will be calculated in 24 hours.
0 Hours will be taken as the time of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare side effects of Dexamethasone and Magnesium sulphate as an adjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block in Total Abdominal Hysterectomy with respect to :
1) Haemodynamic instability
2) Sedation |
1) Haemodynamics will be evaluated by parameters
a) Heart rate.
b)Systolic blood pressure (SBP).
c)Diastolic blood pressure (DBP)
d)Mean blood pressure (MBP).
e)Oxygen saturation (SpO2).
at 0,1,2,4,6,12 and at 24 hrs.
2) Sedation will be evaluated by Ramsay’s Sedation Score at 0,1,2,4,6,12 and at 24 hrs.
0 hours will be taken as the time of block. |
|
|
Target Sample Size
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Postoperative
analgesia aims to reduce the negative consequences of acute postsurgical pain
and help the patient transition smoothly back to normal function. Acute
postoperative pain without adequate management leads to persistent postsurgical
pain or chronic pain. Regional
anaesthesia provides site specific, effective and long lasting anaesthesia. Some of the
abdominal nerve blocks are transversus abdominis plane, subcostal, rectus,
ilioinguinal and iliohypogastric, transversalis fascia plane, and quadratus
lumborum block. Transversus
abdominis plane block is a peripheral nerve block that blocks sensation to
anterior and lateral abdominal wall as well as the parietal peritoneum. The TAP anatomical compartment is located between
the internal oblique and transversus abdominis muscles and
contains the T6 to L1 thoracolumbar nerves. The T9 to T11 Intercostal and T12 Subcostal (SC)
nerves penetrate the transversus abdominis plane compartment posterior to the
midaxillary line. It is one of the most common truncal block for post
operative analgesia in lower abdominal surgeries because of its easy
accessibility, safety and reliability. Ropivacaine, an
enantiomer of Bupivacaine, is a long-acting amide and less likely to penetrate
large myelinated motor fibers so it has relatively shown lesser motor blockade
with safer cardiac profile used for peripheral nerve block. Addition of adjuvant improves the efficacy of
local anaesthetics by reducing the duration of onset of action, prolonging the
duration of action, decrease pain intensity and reduce consumption of systemic
opioids and lesser systemic side effects. Dexamethasone is a highly potent, long acting
glucocorticoid. It acts by inhibiting
potassium conductance by binding to glucocorticoid receptors which
decreases the activity of nociceptive
C-fibres and may also prolong the analgesia duration through systemic
anti-inflammatory effects and local vasoconstrictive action. Magnesium sulphate is an N-methyl D-aspartate
(NMDA) receptor antagonist. It is a non-competitive antagonist which blocks the
voltage- dependent ion channels. This receptor is found in many parts of the
body, including the nerve endings and plays a role in modulating inflammatory
responses and pain responses by preventing central sensitisation caused by
peripheral nociceptive stimulation. Hence, the aim of this study is to compare the
efficacy of Dexamethasone versus Magnesium sulphate with Ropivacaine in
ultrasound guided transversus abdominis plane(TAP) block for patients
undergoing Total Abdominal Hysterectomy. |