Multimodal Pain Management for Cesarean Delivery
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|ClinicalTrials.gov Identifier: NCT02922985|
Recruitment Status : Completed
First Posted : October 4, 2016
Results First Posted : July 24, 2018
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Intravenous acetominophen Drug: Ketorolac, intramuscular Drug: Bupivacaine, subcutaneous Drug: Normal saline||Phase 4|
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.
- 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
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multimodal Pain Management for Cesarean Delivery: A Randomized Control Trial|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||July 2017|
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.
Drug: Normal saline
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.
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.
Drug: Intravenous acetominophen
One dose if 1 gram intravenous to be given pre-surgery
Other Name: Ofirmev
Drug: Ketorolac, intramuscular
One dose of 60 mg Intramuscular to be given at time of skin closure
Other Name: Toradol
Drug: Bupivacaine, subcutaneous
Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
- 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
- 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
- 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).
- 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
- Hospital Length of Stay [ Time Frame: From time of hospital admission to time of discharge home up to 100 days ]Time to discharge from hospital, measured in hours
- 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).
- 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).
- 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.
- NICU Admission [ Time Frame: after birth and before hospital discharge ]Rate of admission to the neonatal intensive care unit
- Need for Respiratory Support [ Time Frame: after birth and before hospital discharge ]neonate receipt of oxygen by nasal cannula or mechanical ventilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922985
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Emily E Hadley, MD||University of Texas|