- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02922985
Multimodal Pain Management for Cesarean Delivery
Multimodal Pain Management for Cesarean Delivery: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Control Group
Patients will receive a placebo dose of all three study medications: Patients will receive the pre-operative dose of IV normal saline placebo within 30 minutes of going to the OR for CD.
The patient will receive the subcutaneous infiltration of 20 mL of subcutaneous normal saline placebo after positioning and preparation but prior to skin incision.
At the time of fascial closure, the patient will receive an IM dose of normal saline placebo.
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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.
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Active Comparator: Multimodal Pain Regimen Group
Patients will receive the actual study medication for all three study medications: Patients will receive the pre-operative dose of IV acetaminophen 1 g within 30 minutes of going to the OR for CD.
The patient will receive the subcutaneous infiltration of either 20 mL of bupivacaine 0.25% after positioning and preparation but prior to skin incision.
At the time of fascial closure, the patient will receive 60 mg of IM ketorolac.
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One dose if 1 gram intravenous to be given pre-surgery
Other Names:
One dose of 60 mg Intramuscular to be given at time of skin closure
Other Names:
Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)
Time Frame: 48 hours post cesarean delivery
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Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents
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48 hours post cesarean delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to First Administration of Opioid Pain Medication Post Operatively
Time Frame: 48 hours post cesarean delivery
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Time, in hours, to first administration of opioid pain medication post operatively
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48 hours post cesarean delivery
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Pain Score at 6-12 Hours Post Operatively
Time Frame: 6-12 hours post-operatively
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Pain score at 6-12 hours post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).
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6-12 hours post-operatively
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Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.
Time Frame: 7 days post delivery
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Number of opioid pain tablets remaining on post-operative day #7 from hospital discharge as reported by patients
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7 days post delivery
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Hospital Length of Stay
Time Frame: From time of hospital admission to time of discharge home up to 168 hours.
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Time to discharge from hospital, measured in hours
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From time of hospital admission to time of discharge home up to 168 hours.
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Pain Score at 24 Hours Post-operatively
Time Frame: 24 hours post-operatively
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Pain Score at 24 Hours Post Operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).
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24 hours post-operatively
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Pain Score at 48 Hours Post-operatively
Time Frame: 48 hours post-operatively
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Pain Score at 48 Hours Post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).
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48 hours post-operatively
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Apgar Score at 5 Minutes
Time Frame: 5 minutes after birth
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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.
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5 minutes after birth
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NICU Admission
Time Frame: after birth and before hospital discharge
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Rate of admission to the neonatal intensive care unit
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after birth and before hospital discharge
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Need for Respiratory Support
Time Frame: after birth and before hospital discharge
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neonate receipt of oxygen by nasal cannula or mechanical ventilation
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after birth and before hospital discharge
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Collaborators and Investigators
Investigators
- Principal Investigator: Emily E Hadley, MD, University of Texas
Publications and helpful links
General Publications
- Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
- Santoso JT, Ulm MA, Jennings PW, Wan JY. Multimodal pain control is associated with reduced hospital stay following open abdominal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2014 Dec;183:48-51. doi: 10.1016/j.ejogrb.2014.10.007. Epub 2014 Oct 14.
- Rosaeg OP, Lui AC, Cicutti NJ, Bragg PR, Crossan ML, Krepski B. Peri-operative multimodal pain therapy for caesarean section: analgesia and fitness for discharge. Can J Anaesth. 1997 Aug;44(8):803-9. doi: 10.1007/BF03013154.
- Munishankar B, Fettes P, Moore C, McLeod GA. A double-blind randomised controlled trial of paracetamol, diclofenac or the combination for pain relief after caesarean section. Int J Obstet Anesth. 2008 Jan;17(1):9-14. doi: 10.1016/j.ijoa.2007.06.006. Epub 2007 Nov 5.
- Hadley EE, Monsivais L, Pacheco L, Babazade R, Chiossi G, Ramirez Y, Ellis V, Simon M, Saade GR, Costantine M. Multimodal Pain Management for Cesarean Delivery: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. Am J Perinatol. 2019 Sep;36(11):1097-1105. doi: 10.1055/s-0039-1681096. Epub 2019 Mar 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Anesthetics, Local
- Ketorolac
- Acetaminophen
- Bupivacaine
Other Study ID Numbers
- IRB 16-0121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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