| CTRI Number |
CTRI/2024/04/065076 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| 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
|
Comparison of three drugs for reducing Postoperative pain in Lower Abdominal Surgeries under Spinal Anesthesia |
|
Scientific Title of Study
|
To compare the safety and efficacy of flupertine maleate, tapentadol hydrochloride and tramadol hydrochloride for post operative analgesia in lower abdominal surgeries under spinal anaesthesia |
| 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 Lakshmi Mahajan |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9855286122 |
| Fax |
|
| Email |
drlakshmimahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaganjot |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8198014504 |
| Fax |
|
| Email |
drgaganjot@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gursimran Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9646831752 |
| Fax |
|
| Email |
gsk.20000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and research |
| Address |
Mehta Road, Vallah, Amritsar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
Sri Gur Ram Das Institute of Medical Sciences and Research |
Main Operation Theatre, Sri Gur Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB |
9814020805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
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 |
100 mg of Flupirtine Maleate, 50 mg of Tapentadol Hydrochloride and 50 mg of Tramadol Hydrochloride tablet orally. |
100 mg of Flupirtine Maleate, 50 mg of Tapentadol Hydrochloride and 50 mg of Tramadol Hydrochloride tablet orally.Pain intensity will be analysed by visual analogue scale (VAS ). Study drugs will be given initially after 3 hours of start of surgery. Patients will be assessed 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours. Subsequent doses will be given after evaluation of VAS, only if VAS more than 3 at an interval of minimum 6 hours. Sedation will be assessed with the Modified Wilson sedation scale after 1 hour and 2 hour of giving the study drug. Safety and tolerability will be assessed by side effects reported by patients and after 48 hours the liver function tests will be assessed again. |
| Intervention |
oral drugs for postoperative analgesia |
Group A will receive - 100 mg of Flupirtine Maleate tablet orally, Group B will receive 50 mg of
Tapentadol Hydrochloride tablet orally. Group C will receive 50 mg of Tramadol
Hydrochloride tablet orally. Pain intensity will be analysed by visual analogue scale
(VAS ). Study drugs will be given initially after 3 hours of start of surgery. Patients will
be assessed 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
Subsequent doses will be given after evaluation of VAS, only if VAS more than 3 at an interval of
minimum 6 hours. Sedation will be assessed with the Modified Wilson sedation scale
after 1 hour and 2 hour of giving the study drug. Safety and tolerability will be
assessed by side effects reported by patients and after 48 hours the liver function tests
will be assessed again.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Physical status based on ASA Grade 1 and Grade 2.
2 Patients posted for lower abdominal surgeries under spinal anaesthesia. appendicectomy, herniorrhaphy, hernioplasty,, excision of lipoma, fistulectomy, haemorrhoidectomy, hydrocoele, varicocoele, Perianal abscess drainage,fissurectomy etc |
|
| ExclusionCriteria |
| Details |
1.Patients with uncontrolled co-existing systemic or metabolic diseases.
2. Patients with any liver disease
3. Pregnant and lactating women.
4. Patients with narcotic addiction.
5. Patients with known hypersensitivity to the study drugs
6. Patient’s refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare efficacy of Flupirtine maleate, Tapentadol
hydrochloride and Tramadol hydrochloride for post operative analgesia in lower
abdominal surgeries performed under spinal anaesthesia in terms of
1. Duration of analgesia after the study drug is given
2. Frequency of doses required of the study drug
3. VAS assessment
4. Frequency of rescue analgesia |
after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse effects during the study period |
after 3 hours of start of surgery, till 48 hours. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/04/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study will be conducted in prospective, randomized double blind manner in Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar in department of anaesthesia and critical care. Introduction: Pain following surgery is an unwanted effect which is to be relieved for the better outcome of surgery and anaesthesia. Flupirtine maleate, Tapentadol Hydrochloride and Tramadol hydrochloride are effective analgesics with minimal side effects. The study will be conducted to compare the efficacy and safety of the study drugs for post-operative pain relief in lower abdominal surgeries performed underspinal anaesthesia. Materials And Methods: The study will be done on 120 patients of American Society of Anaesthesiologist (ASA )grade I and II grades aged 18-60 years. Group A will receive - 100 mg of Flupirtine Maleate tablet orally, Group B will receive 50 mg of Tapentadol Hydrochloride tablet orally. Group C will receive 50 mg of Tramadol Hydrochloride tablet orally. Pain intensity will be analysed by visual analogue scale (VAS ). Study drugs will be given initially after 3 hours of start of surgery. Patients will be assessed 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours. Subsequent doses will be given after evaluation of VAS, only if VAS >3 at an interval of minimum 6 hours. Sedation will be assessed with the Modified Wilson sedation scale after 1 hour and 2 hour of giving the study drug. Safety and tolerability will be assessed by side effects reported by patients and after 48 hours the liver function tests will be assessed again. |