Research comparing two pain relief methods of Diclofenac rectal suppository versus Diclofenac skin patch along with Paracetamol after planned caesarean delivery.

An open label parallel group Randomised controlled trial to compare two multimodal analgesic techniques ( Acetaminophen plus Diclofenac rectal suppository versus Acetaminophen plus Diclofenac transdermal patch ) in women undergoing scheduled caesarean delivery. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107989

Enrollment

140

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: O94-O9A- Other obstetric conditions, not elsewhere classified

Interventions

Intervention1: Acetaminophen plus Diclofenac rectal suppository: Acetaminophen 1 g IV every 8 hours for 24hours (total 3 doses at 0,8 and 16 hours).Diclofenac rectal suppository 100 mg administered im

Eligibility

Inclusion criteria

Inclusion criteria: -Willing to take part in study - Age 18-45years - Singleton pregnancy - Scheduled elective lower segment caesarean section under spinal anaesthesia - Period of gestation 37 to 40 weeks.

Exclusion criteria

Exclusion criteria: - Refusal to give consent - Allergy or contraindication to diclofenac or acetaminophen - ASA class III or above - History of peptic ulcer disease or significant gastrointestinal bleeding - Coagulopathy or thrombocytopenia that preclude spinal anaesthesia - Infection at proposed patch site or rectum - Any contraindication to spinal anaesthesia - Chronic opioid use or analgesic dependence - Pre-existing chronic pain disorder or psychiatric disease interfering with pain assessment - Emergency or unscheduled caesarean - Any intraoperative complication requiring conversion to general anaesthesia - Failed spinal anaesthesia

Design outcomes

Primary

Measure	Time frame
Postoperative pain intensity assessed using NRS at 6,12 and 24 hours after surgeryTimepoint: 24 hours	—

Secondary

Measure	Time frame
1.Total rescue analgesic requirement in first 24 hours. 2.Time to first rescue analgesia. 3.Incidence of adverse effects: nausea, vomiting, pruritis, gastrointestinal side effects, or local reactions at patch site. 4.Time to first breastfeeding. 5.Time to first ambulation.Timepoint: 24 hours	—

Countries

India

Contacts

Public ContactDr Namarta Sharma

Post Graduate Institute of Medical Education and Research ,Chandigarh

aashicool84@gmail.com9915501844

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026