A clinical trial to study the effects of the drug dexmedetomidine in improving the treatment of pain after surgery, in patients undergoing caesarean section

Efficacy and safety of Dexmedetomidine as an adjuvant in local wound infiltration for postoperative pain relief in caesarean section: a prospective, randomized, double blinded study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073871

Enrollment

Registered

2024-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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: Inj. Dexmedetomidine 1 ml (100 mcg): Inj. Dexmedetomidine 1 ml (100 mcg) administered as adjuvant during local wound infiltration before skin closure. This is to be given only ONCE (i.e

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with singleton pregnancy with no obstetric complications (pre-eclampsia, antepartum haemorrhage) 2. Patients undergoing elective caesarean section 3. Patients having ASA grade II 4. Patients with normal BMI (18.5 - 24.9) 5. Patients giving valid consent

Exclusion criteria

Exclusion criteria: 1. Patient refusal. 2. Patients with multiple pregancy. 3. Patients with obstetric complications (antepartum haemorrhage, pre-eclampsia). 4. Patients with history of drug abuse. 5. Patients with history of allergy to the study drug dexmedetomidine. 6. Patients with history of diabetes mellitus, heart, liver, kidney, coagulation or mental disorders. 7. Patients with communication disabilities.

Design outcomes

Primary

Measure	Time frame
The time at which the first analgesic is requested (rescue analgesia) in the postoperative periodTimepoint: At 2, 4, 6, 8, 10 and 12 hours	—

Secondary

Measure	Time frame
Heart rateTimepoint: At 30, 60, 90, 120 minutes;Mean arterial pressureTimepoint: At 30, 60, 90, 120 minutes;Nausea, vomittingTimepoint: At 2, 4, 6, 8. 10 and 12 hours;Time of initiation of breast-feedingTimepoint: At 2, 4, 6, 8, 10 and 12 hours;Time of starting movement in postoperative periodTimepoint: At 2, 4, 6, 8, 10 and 12 hours;Time of starting to eat in postoperative periodTimepoint: At 2, 4, 6, 8, 10 and 12 hours;Total dose of analgesic consumption in 12 hours in postoperative periodTimepoint: At 12 hours;Visual analog scaleTimepoint: At 2, 4, 6, 8, 10 and 12 hours	—

Measure

Time frame

Heart rateTimepoint: At 30, 60, 90, 120 minutes;Mean arterial pressureTimepoint: At 30, 60, 90, 120 minutes;Nausea, vomittingTimepoint: At 2, 4, 6, 8. 10 and 12 hours;Time of initiation of breast-feedingTimepoint: At 2, 4, 6, 8, 10 and 12 hours;Time of starting movement in postoperative periodTimepoint: At 2, 4, 6, 8, 10 and 12 hours;Time of starting to eat in postoperative periodTimepoint: At 2, 4, 6, 8, 10 and 12 hours;Total dose of analgesic consumption in 12 hours in postoperative periodTimepoint: At 12 hours;Visual analog scaleTimepoint: At 2, 4, 6, 8, 10 and 12 hours

—

Countries

India

Contacts

Public ContactDr Nipon Haque

Midnapore Medical College

mandiarunkr87@gmail.com8697633923

Outcome results

None listed

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