Skip to main content
OpenTrials
Completed

NCT Number: NCT02922985

Multimodal Pain Management for Cesarean Delivery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

We are proposing a double-blinded, placebo controlled, randomized trial of patients undergoing elective cesarean delivery. Participants will be randomized to either a control group or study group. This is a double-blinded study, neither participants nor the obstetric or anesthesia team are aware of study assignment. The study group, aka multimodal group, will receive 1 g of IV acetaminophen (ofirmev) within 30 minutes before starting the surgery, regional anesthesia (spinal anesthesia only) with fentanyl, duramorph (morphine) and bupivacaine will be performed as per anesthesia team, the anticipated sight of skin incision will be infiltrated with 20 mL of bupivacaine 0.25% in the subcutaneous space prior to skin incision, and 60 mg of intramuscular (IM) ketorolac (toradol) will be given at the time of fascial closure. The control group will receive a placebo drip within 30 minutes before starting the surgery, regional anesthesia (spinal anesthesia only) with fentanyl, duramorph (morphine) and bupivacaine will be performed as per anesthesia team, the anticipated sight of skin incision will be infiltrated with 20 mL of normal saline in the subcutaneous space prior to skin incision, and an IM dose of placebo at the time of fascial closure. Post-operatively both groups will be managed similarly.

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 Active labor Epidural or Intrathecal 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 DIC or active hemorrhage before randomization Estimated blood loss > 2000 mL

Primary Outcome: The primary outcome of the study is the total opioid (hydrocodone) use in milligrams in the first 48 hours after cesarean delivery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous acetominophen

Drug

One dose if 1 gram intravenous to be given pre-surgery

Other names: Ofirmev

Ketorolac, intramuscular

Drug

One dose of 60 mg Intramuscular to be given at time of skin closure

Other names: Toradol

Bupivacaine, subcutaneous

Drug

Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.

normal saline

Drug

Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.

Primary outcomes

  1. Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)

    Time frame: 48 hours post cesarean delivery

    Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents

Secondary outcomes

  1. Time to First Administration of Opioid Pain Medication Post Operatively

    Time frame: 48 hours post cesarean delivery

    Time, in hours, to first administration of opioid pain medication post operatively

  2. Pain Score at 6-12 Hours Post Operatively

    Time frame: 6-12 hours post-operatively

    Pain score at 6-12 hours post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).

  3. Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.

    Time frame: 7 days post delivery

    Number of opioid pain tablets remaining on post-operative day #7 from hospital discharge as reported by patients

  4. Hospital Length of Stay

    Time frame: From time of hospital admission to time of discharge home up to 168 hours.

    Time to discharge from hospital, measured in hours

  5. Pain Score at 24 Hours Post-operatively

    Time frame: 24 hours post-operatively

    Pain Score at 24 Hours Post Operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).

  6. Pain Score at 48 Hours Post-operatively

    Time frame: 48 hours post-operatively

    Pain Score at 48 Hours Post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).

  7. Apgar Score at 5 Minutes

    Time frame: 5 minutes after birth

    This is the Apgar score of the newborn collected at 5 minutes. Range is from 0-10, with the higher scores meaning a better outcome.

  8. NICU Admission

    Time frame: after birth and before hospital discharge

    Rate of admission to the neonatal intensive care unit

  9. Need for Respiratory Support

    Time frame: after birth and before hospital discharge

    neonate receipt of oxygen by nasal cannula or mechanical ventilation

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Multimodal Pain Management for Cesarean Delivery: A Randomized Control Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2016
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.