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Comparison of the effect of acetaminophen with combination of diclofenac and incisional bupivacaine in controlling pain after Cesarean section

The comparison of the effect of intravenous acetaminophen with diclofenac suppository and incisional bupivacain combination on the first 24hour postoperative pain after cesarian section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201501223213N3
Enrollment
100
Registered
2015-03-01
Start date
2015-02-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Pain after cesarian section. Delivery by cesarean section, unspecified

Interventions

Intervention 1: Before starting surgery patients in group A (acetaminophen) will receive a suppository placebo an then two other doses, all 8 hr apart. At the end of the procedure a 0.6 ml/kg normal s
Treatment - Drugs
Before starting surgery patients in group B (diclofenac + bupivacaine) will receive a suppository diclofenac (50 mg) an then two other doses, all 8 hr apart. At the end of the procedure 1.5 mg/kg bupi
Before starting surgery patients in group A (acetaminophen) will receive a suppository placebo an then two other doses, all 8 hr apart. At the end of the procedure a 0.6 ml/kg normal saline (as placeb

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: full-term pregnant women candidate for elective cesarean section; age: 18 to 45 years;ASA class1 and 2; between 50 to 80kg weight Exclusion criteria : strong indication for spinal anesthesia; emergency cesarean section; opioid addiction; anxiety and depressive disorders; gastro-esophageal reflux disease; severe renal disease; heart disease liver disease; seizure disease; positive history of hypersensitivity to the drugs used in the study; analgesic consumption in the last 24 hr; non-cooperative patients

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Every 6 hr in the first 24 hr after cesarian section. Method of measurement: NRS score.

Secondary

MeasureTime frame
24 hr morphine consumption. Timepoint: Once, 24 hr after operation. Method of measurement: Total dose of morphine administered (mg).;Time to first request for analgesic after operation. Timepoint: Once after the procedure. Method of measurement: Time interval from the end of the surgery to the first patient's request for analgesic (minute).;Patient's sleep. Timepoint: Next morning after operation. Method of measurement: 3 point scale: 1: good - 2: interrupted - 3: no sleep.;Sedation score. Timepoint: Every 6 hr after operation till 24 hr. Method of measurement: Wilson scale.;Pain intensity at ambulation. Timepoint: Once during ambulation. Method of measurement: NRS.;Drug side effects: nausea and vomiting. Timepoint: Every 6 hr after operation till 24 hr. Method of measurement: 3 points scale: 1: non, 2: nausea, 3: nausea and vomiting.;Patients satisfaction of pain control. Timepoint: Once, 24 hr after operation. Method of measurement: 11 points NRS (0: extremely dissatisfied, 5: neutral, and 10: most satisfied).;Drug side effects: pruritus. Timepoint: Every 6 hr till 24 hr after operation. Method of measurement: 11 points NRS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArash Farbood

Shiraz University of Medical Sciences

farboda@sums.ac.ir; arashfarbood@yahoo.com+98 71 3628 9630

Outcome results

None listed

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