Clinical study to evaluate the efficacy of Tapentadol nasal spray in patients undergoing below umbilical surgery under Spinal Anesthesia.

To evaluate the efficacy of pre-operative Intranasal Tapentadol spray on Postoperative pain in patients undergoing infraumblical surgeries under Spinal Anaesthesia -Randomised Controlled Study. - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064850

Enrollment

Registered

2024-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: - Health Condition 2: N838- Other noninflammatory disorders ofovary, fallopian tube and broad ligament Health Condition 3: R398- Other symptoms and signs involvingthe genitourinary system

Interventions

Intervention1: tapentadol nasal spray: 2puffs (one spray in both nostril) of tapentadol nasal spray which contains 45mg of tapentadol 30 minutes prior to surgery (each puff contains 22.5mg of tapen

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have given written informed consent. 2. Patients aged 18-60 years. 3. Sex- males and females. 4. Patients scheduled for elective infraumblical surgery under spinal anesthesia. 5. Patients with ASA grade I & II.

Exclusion criteria

Exclusion criteria: 1. Patients not willing to give consent and refusing to participate in the study. 2. Patients with any contraindications for neuraxial blockade. 3. Known allergy to any of the study medication. 4. Patient on Opioid dependence. 5. Patients who have taken any medication by intranasal route within the past 72 hours prior to randomization. 6. Patients with severe bronchial asthma, paralytic ileus, nasal allergy, upper respiratory tract infection. 7. Patients with current history of psychiatric illness and being treated with tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans, monoamine oxidase inhibitors, steroids , a-2 agonists or opioid medications within 28 days before scheduled surgery. 8. Patient with any end organ dysfunction. 9. Pregnancy. 10. Patient with history of alcohol abuse, smoking habit, drug abuse. 11. Uncontrolled cases of diabetes mellitus, hypertension, ischemic heart disease, arrhythmias.

Design outcomes

Primary

Measure	Time frame
Heart rate(HR) oxygen saturation (SPO2) Systolic blood pressure(SBP) diastolic blood pressure (DBP) mean arterial pressure(MAP) respiratory rate (RR) Duration of analgesia Duration of sensory block Duration of motor blockTimepoint: Baseline 5min,10min,20min,30min After shifting to OT 3min after SAB 6min 9min 12min 15min 20min 25min 30min 40min 50min 60min 90min 120min	—

Secondary

Measure	Time frame
VAS, RSSTimepoint: Post-operative -immediately -1 hour -2 hours -6 hours -12 hours -24hours	—

Countries

India

Contacts

Public ContactDr Madhu K P

Bangalore medical college and research institute

drmadhukp@gmail.com9343716511

Outcome results

None listed

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