A clinical trial to study effect of a drug dexamethasone given during ceasarean section in reducing pain after caesarean section

A Randomized controlled trial on efficacy of single dose of intraoperative dexamethasone in reducing post operative pain in caesarean section

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/01/061389

Enrollment

100

Registered

2024-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

None listed

Interventions

Intervention1: Dexamethasone group: Single dose intravenous dexamethasone 0.2 mg/kg diluted in 10ml normal saline will be administered intraoperatively after cord clamping and single dose Bupivaciane

Eligibility

Inclusion criteria

Inclusion criteria: All pregnant women aged 18 to 40 years undergoing caesarean section 1. Willing to give written informed consent 2. Elective/Emergency LSCS 3. Primary/Repeat LSCS 4. With Pfannenstiel skin incision 5. Under spinal anaesthesia with 2 ml of 0.5% bupivacaine (hyperbaric) and 25mcg fentanyl

Exclusion criteria

Exclusion criteria: 1. Vertical skin incision 2. Epidural labour analgesia 3. General anaesthesia 4. Allergic/having contraindications to the drugs used in study 5. Uncontrolled diabetes 6. Suffering from neuropathic / chronic pain / migraine 7. History of substance abuse (alcohol/ tobacco/drug) 8. On regular analgesic treatment 9. Unable to understand VAS/Likert scale

Design outcomes

Primary

Measure	Time frame
The efficacy of single dose of intraoperative dexamethasone in reducing postoperative pain in caesarean section over 24 hours using the visual analogue scale (VAS) at rest, movement and coughingTimepoint: 2, 4, 6, 12, and 24 hours after LSCS	—

Secondary

Measure	Time frame
Additional analgesic requirement in terms of frequency of requirement and number of doses required 2. Time in hours from operation to ambulation 3. Time in hours from operation to breastfeeding 4. Maternal satisfaction score using 5 point Likert scale (0 being very dissatisfied and 5 being very satisfied) at 24 hours of surgery 5. Quality of life after 48 hours of surgery using QoR-40 6. Post operative incidence of infection, frequency of need for additional antibiotics, residual pain and analgesic requirement after 6 weeks of surgeryTimepoint: 24 hours, 48 hours and 6 weeks after LSCS	—

Measure

Time frame

Additional analgesic requirement in terms of frequency of requirement and number of doses required 2. Time in hours from operation to ambulation 3. Time in hours from operation to breastfeeding 4. Maternal satisfaction score using 5 point Likert scale (0 being very dissatisfied and 5 being very satisfied) at 24 hours of surgery 5. Quality of life after 48 hours of surgery using QoR-40 6. Post operative incidence of infection, frequency of need for additional antibiotics, residual pain and analgesic requirement after 6 weeks of surgeryTimepoint: 24 hours, 48 hours and 6 weeks after LSCS

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Countries

India

Contacts

Public ContactSakshi Bajaj

AIIMS, New Delhi

vatslad@hotmail.com

Outcome results