| CTRI Number |
CTRI/2024/12/078644 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Analgesic Efficacy of Preemptive Ultrasound Guided Transversus Abdominis Plane Block versus Preemptive Subcutaneous Infiltration of incision site in abdominal surgeries |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of Preemptive Ultrasound Guided Transversus Abdominis Plane Block and Preemptive Subcutaneous Infiltration of incision site in abdominal surgeries(below T8 level):A Prospective randomised comparative study |
| 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 Revelli Mounika |
| Designation |
MBBS, Post graduation (MD) Anaesthesiology and critical care medicine |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology,Sri Venkateswara Institute of Medical Sciences,Alipiri, Chittoor Andhra pradesh Tirupati 517501
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9866404169 |
| Fax |
|
| Email |
mounikarevelli78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peyyety Janaki Subhadra |
| Designation |
Professor,Department of Anaesthesiology and Critical care medicine,SVIMS |
| Affiliation |
Sri Venkateshwara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SVIMS,Alipri,Tirupati,Chittoor,
Andhra Pradesh,
517507
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547655 |
| Fax |
|
| Email |
subhadrapeyyety@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peyyety Janaki Subhadra |
| Designation |
Professor,Department of Anaesthesiology and Critical care medicine,SVIMS |
| Affiliation |
Sri Venkateshwara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SVIMS,Alipri,Tirupati,Chittoor,
Andhra Pradesh,
517507
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547655 |
| Fax |
|
| Email |
subhadrapeyyety@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences SVIMS Tirupati Andhra Pradesh INDIA 517507 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [[NIL]] |
|
|
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 Revelli Mounika |
Sri Venkateswara Institute of Medical Sciences |
Department of Anaesthesiology,SVIMS,Alipri road,Tirupati,Chittoor,Andhra Pradesh,517507
Chittoor
ANDHRA PRADESH |
9866404169
mounikarevelli78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SVIMS,Tirupati |
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 |
| Comparator Agent |
Pre-incisional Subcutaneous infiltration of 0.5% Bupivacaine with Dexmedetomidine (1mcg/kg) |
Subcutaneous infiltration of 0.5% Bupivacaine (2mg/kg) with Dexmeditomidine(1mcg/kg) made to a total volume of 30ml with Normal saline will be given 10 minutes before incision |
| Intervention |
Pre-incisional Ultrasound guided Transversus Abdominis Plane block 0.5% Bupivacaine with Dexmedtomidine |
Transversus abdominis plane block with 0.5% Bupivacaine (2mg/kg) with Dexmeditomidine (1mcg/kg) made to a total volume 40ml,bilaterally(20ml each side)20mins before incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patients of either sex, with ASA physical status grade I, II and III.
-Patients scheduled to undergo abdominal surgeries with incisions from or below T8 dermatomal level
|
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to participate in the study.
2.Patients with history of hypersensitivity to study drugs.
3.Patients with morbid obesity (BMI more than 35 kg/m2).
4.Patients with previous abdominal surgeries.
5.Patients with hepatic, renal, cardiac and seizure disorders.
6.Pregnant and lactating women.
7.Patients who cannot understand or interpret VAS for pain assessment.
8.Patients who could not be extubated on table.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total morphine consumption in both groups in the first 24hours following surgery |
Total morphine dosage requirement according to VAS score will be noted as per patient requirement within 24 hours of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the effect of preemptive analgesia on the hemodynamic response to surgical incision in both groups
2.To assess magnitude of pain by Visual analogue scale at different time points
3.To assess the time for first request of rescue analgesia
4.To assess the time after which patient can do deep breathing exercises with the help of incentive spirometry
5.To assess the overall patients satisfaction score by Visual analogue scale at the time of discharge from Post anaesthesia care unit.
|
1. Hemodynamic response (HR, SBP, DBP, MAP) pre incision(T0), Immediately after surgical incision T1 & at 1min(T2), 2min(T3), 3min(T4) after surgical incision.
2. VAS score 0,15,30,45 minutes & 1,2,4,6,24 hours after surgery
3. The time at which first request of rescue analgesia is noted in post operative period
4. Time after which patient can do incentive spirometry is noted
5. overall patients satisfaction score noted by Visual analogue scale at the time of discharge from PACU. |
|
|
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)
|
31/12/2024 |
| 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="1"
Months="0"
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
|
Pain is an important hindrance to recovery from
surgery and anaesthesia in the post-operative period. Abdominal incisions are
commonly associated with persistant post-operative pain,affects respiratory
function and also associated with increased analgesic requirement.
Opioids are the main stay of treatment for postoperative
pain,even though opioids are the most effective forms of medication that are
being used in relieving pain they are associated with severe systemic side
effects.
Therefore,a general goal is to minimize exposure to the side
effects of prolonged systemic narcotics while ensuring adequate pain relief.
Preemptive analgesia is defined as "treatment initiated
before the surgical procedure in order to prevent establishment of central
senstitization evoked by the incisional and inflammatory injuries occuring
during surgery and in the early post-operative period".
Effective preemptive analgesic technique requires multimodal
interception of pain perception,increasing threshold for nociception and
decreasing or blocking pain receptor activation.Because of this protective
effect on the nociceptive systems,preemptive analgesia has the potential to be
more efficient than analgesic treatment initiated after surgery
This study will be done to evaluate and compare the
usefulness of TAP block versus subcutaneous infiltration as preemptive
analgesia in abdominal surgeries below T8 level
|