| CTRI Number |
CTRI/2023/05/052229 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
01/05/2023 |
| 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 to study the pain relieving effect of two different doses of buprenorphine patch in post-operative pain relief in patients undergoing laparoscopic surgeries under general anaesthesia |
|
Scientific Title of Study
|
Comparative study between transdermal buprenorphine patch 5 mcg/hour and 10 mcg/hour in post-operative pain management administered pre-emptively in laparoscopic surgeries under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ZAINAB HAMEEDA BEGAM S |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL , K.K. NAGAR . |
| Address |
ESIC MEDICAL COLLEGE AND HOSPITAL,
DEPARTMENT OF ANAESTHESIOLOGY,
B BLOCK , 1ST FLOOR ,
ESIC MEDICAL COLLEGE AND HOSPITAL,
K.K.NAGAR
CHENNAI 600078
DEPARTMENT OF ANAESTHESIOLOGY,
B BLOCK , 1ST FLOOR ,
ESIC MEDICAL COLLEGE AND HOSPITAL,
K.K.NAGAR
CHENNAI 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
7550040977 |
| Fax |
|
| Email |
zainabsulthan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ZAINAB HAMEEDA BEGAM S |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL , K.K. NAGAR . |
| Address |
ESIC MEDICAL COLLEGE AND HOSPITAL,
DEPARTMENT OF ANAESTHESIOLOGY,
B BLOCK , 1ST FLOOR ,
ESIC MEDICAL COLLEGE AND HOSPITAL,
K.K.NAGAR
CHENNAI 600078
DEPARTMENT OF ANAESTHESIOLOGY,
B BLOCK , 1ST FLOOR ,
ESIC MEDICAL COLLEGE AND HOSPITAL,
K.K.NAGAR
CHENNAI 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
7550040977 |
| Fax |
|
| Email |
zainabsulthan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ZAINAB HAMEEDA BEGAM S |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL , K.K. NAGAR . |
| Address |
ESIC MEDICAL COLLEGE AND HOSPITAL,
DEPARTMENT OF ANAESTHESIOLOGY,
B BLOCK , 1ST FLOOR ,
ESIC MEDICAL COLLEGE AND HOSPITAL,
K.K.NAGAR
CHENNAI 600078
DEPARTMENT OF ANAESTHESIOLOGY,
B BLOCK , 1ST FLOOR ,
ESIC MEDICAL COLLEGE AND HOSPITAL,
K.K.NAGAR
CHENNAI 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
7550040977 |
| Fax |
|
| Email |
zainabsulthan@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND HOSPITAL , K.K.NAGAR , CHENNAI |
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL AND HOSPITAL |
| Address |
ESIC MEDICAL COLLEGE AND HOSPITAL , K.K. NAGAR ,
CHENNAI - 600078 |
| 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 |
| PROF DR ILANGO GANESAN |
ESIC MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY,
B BLOCK, 1ST FLOOR ,
10, Ashok Pillar Main Riad, KK Nagar, Chennai 600078
Chennai
TAMIL NADU |
9884149429
gilang@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC Medical College & Hospital, KK Nagar, Chennai 600078 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: K35-K38||Diseases of appendix, (5) ICD-10 Condition: K40-K46||Hernia, (6) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (7) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PRE-EMPTIVE ANALGESIA WITH TRANSDERMAL BUPRENORPHINE PATCH 10 MCG/HOUR |
ADMINISTERED 12 HOURS BEFORE SURGERY IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES UNDER GENERAL ANAESTHEISA.
IT IS ADMINISTERED ONCE.
ROUTE : TRANSDERMAL
DOSE : 10 MCG/HOUR
IT CONTINUES TO RELEASE THE DRUG FOR 1 WEEK TIME.
PATIENT IS MONITORED FOR 48 HOURS TO ASSESS THE INTENSITY OF PAIN. |
| Comparator Agent |
PRE-EMPTIVE ANALGESIA WITH TRANSDERMAL BUPRENORPHINE PATCH 5 MCG/HOUR |
ADMINISTERED 12 HOURS BEFORE SURGERY IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES UNDER GENERAL ANAESTHEISA.
IT IS ADMINISTERED ONCE.
ROUTE : TRANSDERMAL
DOSE : 5 MCG/HOUR
DURATION OF ACTION : 1 WEEK.
PATIENT IS MONITORED FOR 48 HOURS TO ASSESS THE INTENSITY OF PAIN. |
| Intervention |
PRE-OPERATIVE ADMINISTRATION OF TRASDERMAL BUPRENORPHINE PATCH |
ADMINISTERED 12 HOURS BEFORE SURGERY IN PATIENTS UNDER LAPAROSCOPIC SURGERIES UNDER GA.
IT IS ADMINSTERED ONCE.
IT RELEASES DRUG FOR 1 WEEK TIME.
PATIENT IS MONITORED FOR 48 HOURS TO ASSESS THE INTENSITY OF PAIN RELIEF.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I, II
Patients posted for laparoscopic surgeries under GA
|
|
| ExclusionCriteria |
| Details |
• Patient refusal
• Patients with skin allergy
• Patients with severe hepatic and renal dysfunction
• Pregnant and lactating women
• Bleeding disorders
• Respiratory diseases such as chronic obstructive pulmonary disease, bronchial asthma
• Hypersensitivity to study drug
• Epileptic patients
• ASA III ,IV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain-free duration measured using VAS scale |
From the time of extubation upto 48 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The amount of analgesics required over 48 hrs.
Variation in heart rate, NIBP, MAP intra- operatively.
Level of sedation using Ramsay sedation scale
|
serially upto 48 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/05/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative pain management is an essential
component for patient undergoing major surgery. Adequate pain management is a
challenge to the anaesthesiologists as there are many adverse effects
associated with pain physiologically and psychologically which can hamper the
normal recovery process.
The pain signal
transmission evoked by tissue damage leads to sensitization of the peripheral
and central pain pathways. This sensitization can be prevented by blocking the
pain signal transmission completely from the surgical site.
Pre-emptive
analgesia is a treatment to reduce this sensitization which is initiated before
surgery. Due to this protective effect on the nociceptive system, pre-emptive
analgesia has the potential to be more effective than a similar analgesic
treatment initiated after surgery. This helps to reduce immediate
post-operative pain and reduces the total amount of analgesics required the in
post-operative period.
Buprenorphine is a opioid analgesic
that has partial agonistic action at µ receptors and antagonistic action on κ receptor.
It is a synthetic thebaine congener. It is a highly lipid-soluble µ analgesic
with great analgesic potency. It is 50 times more potent than morphine but with
lower intrinsic activity and has ceiling effect. The onset of action is slower
and duration of action is longer. After a single dose, analgesia lasts for 6–8
hours . Transdermal buprenorphine provides a non-invasive method
of drug release at a controlled rate. It ensures constant and predictable serum
buprenorphine levels over a prolonged period. Buprenorphine is homogenously
incorporated in a solid polymer matrix patch which is applied to the skin. The
adhesive buprenorphine patch is non-invasive, simple and compliant method of
drug delivery. It slowly and continuously releases the drug into the systemic
circulation. These characteristics suggest that transdermal
buprenorphine may be useful in the postoperative pain management for patients
undergoing laparoscopic surgeries under GA
The study is conceptualized to compare
the intensity of pain relief of pre-emptively administered transdermal buprenorphine
patch 5 mcg/hr with 10 mcg/hr in post-operative analgesia. |