Multimodal Pain Management for Cesarean Delivery

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Acetaminophen; Bupivacaine; Ketorolac

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 <50 kilograms

• Uncontrolled hypertension

• Ischemic cardiac disease

• Congestive heart failure

• Thrombocytopenia, platelet count <150,000/microliter

• Preeclampsia including Hemolysis Elevated Liver enzymes Low Platelets syndrome

• Disseminated intravascular coagulation (DIC) or active hemorrhage before randomization

• Estimated blood loss > 2000 mL