| CTRI Number |
CTRI/2025/09/095369 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison flupirtine with pregabalin for post
operative analgesia in laparoscopic gallbladder removal surgeries |
|
Scientific Title of Study
|
Comparison of Pre-emptive Flupirtine with Pregabalin for Postoperative Analgesia in Laparoscopic Cholecystectomy - A Randomized
Control 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 |
MOHAMMED ISMAIL NABEEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sapthagiri Institue of Medical Sciences and Research centre |
| Address |
Department of Anaesthesia,
ground floor,
Sapthagiri Institue of Medical Sciences and Research Centre.
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9902014829 |
| Fax |
|
| Email |
ismailnabeel76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANAND TIPPANNA TALIKOTI |
| Designation |
PROFESSOR |
| Affiliation |
Sapthagiri Institue of Medical Sciences and Research centre |
| Address |
Department of Anaesthesia,
Ground floor,
Sapthagiri Institue of Medical Sciences and Research centre.
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9986093837 |
| Fax |
|
| Email |
drttanand@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHAMMED ISMAIL NABEEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sapthagiri Institue of Medical Sciences and Research centre |
| Address |
Department of Anaesthesia,
Ground floor,
Sapthagiri Institue of Medical Sciences and Research centre.
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA
560076
India |
| Phone |
9902014829 |
| Fax |
|
| Email |
ismailnabeel76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institue of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institue of Medical Sciences and Research Centre |
| Address |
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
| 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 MOHAMMED ISMAIL NABEEL |
Sapthagiri Institue of Medical Sciences and Research centre |
Department of Anaestheisa ground floor, Sapthagiri hospital, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara.
Bangalore
KARNATAKA |
9902014829
ismailnabeel76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
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 |
| Intervention |
Administer one of the two drugs. |
Patients will be divided into two groups
Group A: 30 patients will receive oral Flupirtine 200mg 2h prior to the induction of
anaesthesia with sips of water.
Group B: Pregabalin- 30 patients will receive 150 mg oral pregabalin about 2h prior to the induction of anaesthesia with sips of water.
|
| Comparator Agent |
FLUPIRTINE and PREGABALIN |
FLUPIRTINE AND PREGABALIN being compared as pre-emptive analgesics for post operative analgesia which is assessed by Visual analogue scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients willing to give informed consent
2)Patient undergoing elective laparoscopic cholecystectomy under general anaesthesia
3)ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with history of allergy to the studied medications
• Patients with a history of psychiatric disorders or presently on analgesic or opioid medication
within 28days of scheduled surgery
• Pregnancy
• Alcohol abuse
• Patients with history of liver, kidney, heart disease
• Patients with chronic pain on medication |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oral Flupirtine and Pregabalin in terms of postoperative analgesia by visual analogue scale. |
post operative analgesia will be assessed using vas scale at intervals of 30mins until patient receives rescue analgesic. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2026 |
| 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="5"
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
|
The selected patients will be randomly allocated to one of the following two groups irrespectiveof age or gender. Randomization will be achieved by using random number tables.Group A: Flupirtine- 30 patients will receive oral Flupirtine 200mg 2h prior to the induction of anaesthesia with sips of waterGroup B: Pregabalin- 30 patients will receive 150 mg oral pregabalin about 2h prior to the induction of anaesthesia with sips of water
patients will be visited in their respective wards on the day before the surgery for preanesthetic check-up. After a thorough history, general and systemic examination will be performed, and their laboratory data will be reviewed. Before proceeding for the study, written and informed consent will be taken from the patients scheduled for surgery. On the morning of the surgery, patients will be visited in the preoperative ward about 2h before the induction of anaesthesia and depending on their position in the random number tables, they will be given one of the two oral drugs (pregabalin or flupirtine) with sip of water by an anaesthesiologist not involved in the study before transferring to the operation room.
The patient will be pre medicated with Inj Glycopyrrolate 0.2mg and Inj Midazolam 1mg; induced with Inj Fentanyl 2mcg/kg and Inj Propofol 2mg/kg and orotracheal intubation facilitated by Inj Vecuronium 0.1mg/kg. Anaesthesia will be maintained with air, O2 and Sevoflurane 2%. Supplemental vecuronium will be given as per requirement. All patients will be given a single IV dose of antiemetic, Inj ondansetron 4 mg and Inj Paracetamol 1g. After surgery Inj glycopyrrolate 0.01mg/kg + Inj Neostigmine 0.05mg/kg to be given as reversal. After extubation and ensuring adequate ventilation, patients will be transferred to the post operative room.
Post operative analgesia and sedation will be assessed using Visual Analog Score (VAS score) and Ramsay sedation score (RSS) and noted
|