| CTRI Number |
CTRI/2024/04/065963 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| 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
|
Comparision of USG guided Transversus Abdominis Plane Block for analgesia during first 24 hours after unilateral hernia surgery |
|
Scientific Title of Study
|
A randomized double blinded comparative interventional study to assess the post operative analgesic effect of Magnesium sulphate versus Dexamethasone as adjuvants to Bupivacaine in ultrasound guided Transversus Abdominis Plane Block in open unilateral hernia surgeries |
| 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 Anupama Gupta |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia, Second floor, Dhanwantari building, SMS Medical College, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414240245 |
| Fax |
|
| Email |
anupamag213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kartika Phulwaria |
| Designation |
Post graduate resident |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia, Second floor, Dhanwantari building, SMS Medical College , Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7597535191 |
| Fax |
|
| Email |
kartikaphulwaria01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kartika Phulwaria |
| Designation |
Post graduate resident |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia, Second floor, Dhanwantari building, SMS Medical College , Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7597535191 |
| Fax |
|
| Email |
kartikaphulwaria01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMS Medical College and attached hospitalls |
| Address |
Department of Anaesthesia dhanwantari building second floor
SMS Medical College Jaipur |
| Type of Sponsor |
Government 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 Anupama Gupta |
SMS MEDICAL COLLEGE |
Department of Anaesthesia Dhanvantri OPD Building Second floor SMS hospital
Jaipur
RAJASTHAN |
9414240245
anupamag213@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee SMS Medical College and att hospitalls |
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 |
| Comparator Agent |
TAP block using 20 ml of 0.25% Bupivacaine in 35 patients |
USG guided TAP block using 20 ml of 0.25% Bupivacaine in patients undergoing open unilateral hernia surgeries under spinal anaesthesia taken as control group and compare the dose of first rescue analgesic Tramadol 2mg per kg given paracetamol 15mg per kg 8 hourly and post operative analgesic efficacy using NRSscores during first 24 hours after surgery |
| Intervention |
TAP block using20 ml of 0.25% Bupivacaine+ 8mg of Dexamethasone in 35 patients |
USG guided TAP block using 0.25% ofbupivaciane +8mg Dexamethasone in patients undergoing open unilateral hernia surgeries under spinal anaesthesia amd compare the dose of first rescue analgesic
Tramadol 2mg per kg given Paracetamol 15mg per kg 8 hourly when NRS more than 4 and post operative analgesic efficacy using NRS score during first 24 hours after surgery at various intervels |
| Intervention |
Transversus Abdominis Plane TAP block using 20 ml of 0.25% Bupivacaine+ 250 mg of MgSO4 in 35 patients |
USG guided TAP block using 20 ml of 0.25% Bupivacaine +250 mg MgSO4 in patients undergoing open unilateral hernia surgeries under spinal anaesthesia and compare the dose of first rescue analgesic
Tramadol 2mg per kg given Paracetamol 15mg perkg 8 hourly when NRS more than 4 and post operative analgesic efficacy using NRS score during first 24 hours after surgery at various intervels |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients consenting to participate between age 18-60 years undergoing elective open unilateral hernia surgeries under spinal anaesthesia.
Patients belonging to ASA grade I and II.
Weight between 40-80 kgs.
|
|
| ExclusionCriteria |
| Details |
Patients not consenting to participate
Patients having history of chronic use of analgesia for pain
Patients allergic to drugs used in the study
Patients with psychosis or gross neurological disorders
Patients with body mass index more than 35
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To assess and compare the mean dose of rescue analgesic requirement in first 24 hours conferred by bupivacaine with magnesium sulphate versus bupivacaine with dexamethasone in USG guided TAP block in open unilateral hernia surgeries
2 To compare and assess NRS scores between two groups
3 To assess and compare the level of patient satisfaction betweeen two groups using patient satisfaction index |
1 To assess and compare the mean dose of rescue analgesic requirement in first 24 hours conferred by bupivacaine with magnesium sulphate versus bupivacaine with dexamethasone in USG guided TAP block in open unilateral hernia surgeries
2 To assess and compare NRS scores between two groups
3 To assess and compare the level of patient satisfaction betweeen two groups using patient satisfaction index |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine and compare the difference in hemodynamic
( heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, spo2) differences in both groups.
2.To observe the incidence of side effects and complications if any. |
1. To determine the change in the hemodynamic parameters (HR, SBP,DBP,MAP,Spo2) in groups 24 hours post operatively.
2. To observe side effect or comlipcations,if any |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 4 |
|
Date of First Enrollment (India)
|
29/04/2024 |
| 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="10"
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
|
Inguinal hernia is one of the most commonly performed surgical procedures which is associated with moderate to severe intensity of pain that is at its most extreme in the first 24 hours post surgery. Inadequate pain relief in these patients can lead to delayed recovery extended duration of hospital stays and also lead to persistent pain after surgery Abdominal field blocks and costo iliac block have been used in anaesthesia for surgery involving the anterior abdominal wall for severe decades through innervation of the anterior abdominal wall arises from the spinal nerves T7 to L1. The aim of TAP block is to deposit local anaesthetic in the plane between internal oblique and Transversus abdominis muscle. By blocking these nerves, the innervation to abdominal skin, muscles and parietal peritoneum can be interrupted. The somatic component is blocked and aids in decreased consumption of opioid in 24 hours after surgery as opioid causes nausea, constipation and urinary retention as well as negative consequences such as respiratory depression, hormonal , sedation and post operative ileus. Various adjuvants have been used with local anaesthetics to improve the quality and duration like Dexamethasone, magnesium sulphate, adenosine and buprenorphine ,dexmedetomidine in TAP block to prolong the analgesic action in lower abdomen
Bupivacaine is a long acting aminoamide local anaesthetic agent. Chemically Bupivacaine is a racemic mixture of levo and dextro isomers. It blocks impulse conduction in nerve fibres via reversible of sodium influx and it has more action on A and C fibres which are meant for pain transmission Magnesium sulphate is a N methyl D aspartate antagonist. It acts by non competitive antagonism blocks the voltage dependent ion channel . It blocks calcium influx which inhibits central sensitisation and decrease pre existing pain hypersensitivity and provides better post operative analgesia Dexamethasone is a long acting glucocorticoid . It inhibits potassium conductance by binding to receptors which decrease the activity of nociceptive Cfibres and prolong the duration of analgesia through anti inflammatory effects and local vasoconstrictive action |