Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age16+
SponsorThomas Jefferson University

About this trial

Cesarean delivery is a commonly performed surgical procedure associated with worse postpartum pain when compared to vaginal birth. Uncontrolled postpartum pain is associated with increased neonatal and maternal risks. Multimodal non-opioid pain medications, including acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are the preferred first-line therapies. There is no standard practice, however, on best dosing schedules (ie staggered or different time v. simultaneous or same time). This protocol describes a randomized clinical trial aimed to determine whether staggered dosing of acetaminophen and NSAIDs in superior to simultaneous dosing in controlling post-cesarean pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>/= 34 weeks gestation

Singleton pregnancy

Delivery via cesarean section under regional anesthesia

Disqualifiers

Contraindication to acetaminophen or NSAIDs

Current or history of opioid use or misuse

Intrauterine fetal demise

Major congenital anomaly

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetaminophen

    Drug

    Acetaminophen 1000 mg q6H

  • NSAID (Ketorolac/Ibuprofen)

    Drug

    NSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)

Treatment groups

825 Participants
are divided into 2 treatment groups
Group A: StaggeredActive comparator 2 interventions
Group B: SimultaneousActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Postpartum pain control

Visual analog pain score (VAS) with movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

Time frame
48 (+/- 2) hours postpartum
2

Opioid consumption

Opioid consumption (in total morphine milligram equivalents (MME))

Time frame
Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days)

Secondary outcomes

1

Postpartum pain at 6 hours

Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

Time frame
6 hours (+/- 1 hour) post-op
2

Postpartum pain at 12 hours

Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

Time frame
12 hours (+/-2 hours) post-op
3

Postpartum pain at 24 hours

Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

Time frame
24 hours (+/-2 hours) post-op
4

Postpartum pain at 48 hours

Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

Time frame
48 hours (+/- 2 hours) post-op.

Other outcomes

Sponsors and contacts

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