The TraD Trial

Study to assess the feasibility, safety, and effectiveness of high-dose oral tramadol and rectal diclofenac in controlling post-caesarian section pain in women admitted at Nkhata Bay district hospital: protocol for a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202206670556358

Enrollment

Registered

2022-06-21

Start date

2022-07-10

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Post-operative Pain Anaesthesia

Interventions

Oral Tramadol and rectal diclofenac

Standard Care

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 18 years or older, elective or emergency caesarian section

Exclusion criteria

Exclusion criteria: without pre-eclampsia, intra-operative or obstetric complications such as post-partum hemorrhage (PPH), surgical infections, ASA III or IV, use of general anesthesia, history of peptic ulcer disease, gastric bleeding, recent opioid use (within 30 days), renal or liver disease, chronic pain disorders or those who refuse consent

Design outcomes

Primary

Measure	Time frame
change in self-reported pain scores at rest	—

Secondary

Measure	Time frame
risk of analgesic supplementation;the relative cost-effectiveness of intervention regimens;Odds Ratio of drug-related side effects ;mean difference in patient satisfaction scores	—

Countries

Malawi

Contacts

Public ContactSibongile Kaphaizi

Research Officer

skaphaizi@gmail.com+265998595308

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026