Comparison of three drugs for reducing Postoperative pain in Lower Abdominal Surgeries under Spinal Anesthesia

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 - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065076

Enrollment

120

Registered

2024-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 analgesiaTimepoint: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.	—

Measure

Time frame

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 analgesiaTimepoint: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.

—

Secondary

Measure	Time frame
Incidence of adverse effects during the study periodTimepoint: after 3 hours of start of surgery, till 48 hours.	—

Countries

India

Contacts

Public ContactDr Gursimran Kaur

Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar

drgaganjot@yahoo.com8198014504

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026