CTRI Number |
CTRI/2022/08/044612 [Registered on: 03/08/2022] Trial Registered Prospectively |
Last Modified On: |
28/07/2022 |
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
|
Comparison of two different drug effect for postoperative analgesia in Nephrectomy surgery. |
Scientific Title of Study
|
Comparative study of Tramadol and Buprenorphine Transdermal patch for postoperative analgesia in Nephrectomy surgery. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Prakash Gangwani |
Designation |
Junior resident |
Affiliation |
Mahatma Gandhi Medical College and Hospital |
Address |
Department of Anaesthesiology, Critical care and Pain Management,Mahatma gandhi medical college and hospital
Mahatma gandhi medical college and hospital,sitapura,jaipur Jaipur RAJASTHAN 302022 India |
Phone |
9408936833 |
Fax |
|
Email |
prakashgangwani54@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Birbal Baj |
Designation |
Professor |
Affiliation |
Mahatma Gandhi Medical College and Hospital |
Address |
Department of Anaesthesia, Mahatma Gandhi Medical College and hospital
Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur Jaipur RAJASTHAN 302022 India |
Phone |
8107788625 |
Fax |
|
Email |
birbalbaj@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Col RCGupta |
Designation |
Professor |
Affiliation |
Mahatma Gandhi Medical College and Hospital |
Address |
Department of Anaesthesia, Mahatma Gandhi Medical College and hospital
Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur Jaipur RAJASTHAN 302022 India |
Phone |
9352702539 |
Fax |
|
Email |
rc.gupta@yahoo.co.in |
|
Source of Monetary or Material Support
|
Mahatma Gandhi Medical College and Hospital |
|
Primary Sponsor
|
Name |
Mahatma Gandhi Medical College |
Address |
Sitapura Jaipur Rajasthan India |
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 Prakash Gangwani |
Mahatma Gandhi Medical College and Hospital |
Department Of Anaesthesia,
Operation Theatre. Jaipur RAJASTHAN |
9408936833
prakashgangwani54@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Buprenorphine Transdermal Patch 10 mcg/hr for duration 7 Days. |
Buprenorphine Transdermal patch 10mcg/hr will be applied 12 hrs prior to Nephrectomy Surgery. |
Comparator Agent |
Inj Tramadol 100mg OD for 7 Days. |
Inj Tramadol 100mg OD will be given just before extubation. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA Grade I/II
Patient UnderGoing Nephrectomy Surgery
Patient Written And Informed Consent. |
|
ExclusionCriteria |
Details |
Allergy to Study Drug
ASA Grade III/IV. |
|
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 |
To compare Analgesic effect postoperatively between Tramadol and Transdermal Buprenorphine patch in Nephrectomy patients. |
5-7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
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)
|
01/09/2022 |
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)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Postoperative pain is a major
concern for patients undergoing Nephrectomy surgery. Pain can be associated
with adverse physiological and psychological effects hampering the normal
recovery process. Preventive analgesia, initiated before
the surgical procedure, can theoretically reduce pain sensitization, but
multiple clinical studies have failed to demonstrate convincing clinical
benefit.
Buprenorphine, a derivative of
the opium alkaloid thebaine, is a more potent and longer lasting analgesic. Its
dissociation from opioid receptor binding is slow which probably accounts for
its longer duration of action. The lack of delta receptor agonist activity may
be responsible for the observation that buprenorphine is less likely to induce
tolerance on chronic use.
Buprenorphine is used
clinically for the treatment of moderate-to-severe pain, including
perioperative analgesia. A transdermal patch formulation of buprenorphine
has recently been introduced in the Indian market. Although expensive, this
mode of delivery has several potential benefits over oral and parenteral
administration. These include noninvasive dosing, better
absorption, lack of first-pass metabolism, and steady plasma concentration. The
buprenorphine patch releases the analgesic steadily over 7 days and has been
successfully used to treat a variety of chronic pain conditions. However,
there is limited clinical experience of its utility in postoperative pain.
Tramadol is a centrally acting analgesic with weak opioid
agonist. Its safety is well established by the fact that the clinically
relevant respiratory depression is not seen with tramadol and it has low
dependence and abuse potential. All these properties make tramadol as the ideal
drug for the management of post-operative pain. Hence, tramadol is one of the
most commonly used analgesics in post-operative period. Tramadol has good
bioavailability (70%–90%); hence, it has been used for providing post-operative
analgesia. It should be used cautiously in patients with renal failure due to
risk of accumulation. |