Phase 4
N=120
Multimodal Pain Management for Cesarean Delivery
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02922985 ↗Enrolled (actual)
120
Serious AEs
2.5%
Results posted
Jul 2018
Primary outcome: Primary: Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD) — 42; 49.5 morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intravenous acetominophen (Drug); Ketorolac, intramuscular (Drug); Bupivacaine, subcutaneous (Drug); Normal saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD) |
42; 49.5 | — |
| SECONDARY Time to First Administration of Opioid Pain Medication Post Operatively |
6.05; 6.35 | — |
| SECONDARY Pain Score at 6-12 Hours Post Operatively |
6; 6 | — |
| SECONDARY Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription. |
18; 19 | — |
| SECONDARY Hospital Length of Stay |
50.2; 50 | — |
| SECONDARY Pain Score at 24 Hours Post-operatively |
5; 6 | — |
| SECONDARY Pain Score at 48 Hours Post-operatively |
4; 3 | — |
| SECONDARY Apgar Score at 5 Minutes |
9; 9 | — |
| SECONDARY NICU Admission |
2; 6 | — |
| SECONDARY Need for Respiratory Support |
0; 4 | — |
Summary
Opioid use and abuse has become a major medical problem in the United States. Over prescription of opioid medications is a major contributor to this growing problem. Cesarean delivery (CD) is the most commonly performed surgery in the US and women are generally given opioid medications for postoperative pain management. This is not a common practice in other developed countries. We believe that a multimodal pain management strategy is superior to current practices for control of postoperative pain after CD and will lead to a decrease in the use of opioid medications. This will have beneficial effects on patients' recovery and bonding with their newborns, as well as societal effects in reducing the burden of opioid abuse in the US. Our objective is to investigate the use of a multimodal pain regimen in pregnant patients undergoing CD. This is a randomized double-blinded, placebo controlled trial. The multimodal intervention consists of a pre-operative dose of IV acetaminophen (Ofirmev), infiltration of subcutaneous bupivacaine prior to skin incision, and a dose of IM ketorolac at time of fascial closure. These study medications are currently used in our patient population but not in a standardized fashion, not in every patient, and not always in combination with each other. The control group will receive placebo IV infusion preoperatively and an IM injection at fascial closure, and subcutaneous infiltration with normal saline before skin incision. Both groups will receive spinal regional anesthesia as per anesthesia team and then postoperatively, both groups will receive the current standard of care, which consists postoperative hydrocodone/acetaminophen and ibuprofen as needed depending on pain score. Our primary outcome of interest will be the total opioid intake in the first 48 hours after surgery. Secondary outcomes include time to first opioid given, pain scores at 6-12, 24 and 48 hours post op, and total number of opioid tablets left after discharge on post op day number 7. We will also evaluate patient satisfaction scores and total length of hospital stay. We will evaluate neonatal outcomes including Apgar scores, cord blood gases, immediate newborn complications in the first 48 hours after birth, and any infant adverse outcomes related to maternal opioid use up to 4 weeks of life. Our hypothesis is that our multimodal pain regimen will decrease the total opioid requirement in the first 48 hours after surgery.
Eligibility Criteria
Inclusion Criteria
- Women who are 18 - 45 years of age at the time of cesarean delivery with the ability to give informed consent
- Elective cesarean delivery
- Gestational age ≥ 34 weeks
- Fluent in either English or Spanish
- Spinal anesthesia
Exclusion Criteria
- Urgent or emergent CD
- Epidural or combined spinal epidural regional anesthesia
- General anesthesia
- Patients with a contraindication for regional anesthesia
- Acute or chronic hepatic disease
- Acute or chronic renal disease
- Active asthma
- Gastrointestinal ulceration
- Inflammatory bowel disease
- Allergy to ketorolac, acetaminophen, hydrocodone, codeine, ibuprofen or bupivacaine
- Opioid dependence
- Non reassuring fetal or maternal status requiring immediate delivery
- Placenta previa or accreta
- Acute or chronic pain disorder
- Maternal weight 2000 mL
Data sourced from ClinicalTrials.gov (NCT02922985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.