Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section

Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control: a Randomized Controlled Trial

The purpose of this study is to determine if giving an injection of numbing medication at the incision at the end of cesarean will help control pain AFTER cesarean delivery. This study seeks to assess pain relief with incisional infiltration of local anesthetic during cesareans performed under spinal anesthesia also using intrathecal opioids. Participants will receive the usual regimen of pain medication in spinal anesthesia. At the end of the cesarean delivery, while the participants are still under the spinal medication, participants will receive an injection, at the incision, either numbing medication (with or without epinephrine) or sterile saline. After the cesarean delivery, participants will receive, by mouth, commonly prescribed pain medications - these medications are oxycodone (an opioid/ narcotic), acetaminophen (or more commonly known as Tylenol), and ibuprofen.

Study Overview

• Status: Terminated
• Conditions: Pain, Referred
• Intervention / Treatment: Drug: Bupivacaine; Drug: Morphine; Drug: Fentanyl; Drug: Epinephrine; Other: Saline solution

Detailed Description

The study assesses addition of subcutaneous bupivacaine with and without epinephrine to the standard intrathecal morphine/fentanyl combination given during spinal anesthesia during elective cesarean delivery on postoperative pain control as measured by postoperative usage of oral opioids and a postoperative pain assessment scale. Comparing post-op pain scores and oxycodone usage in patients who receive just intrathecal morphine to patients who receive intrathecal morphine plus subcutaneous bupivacaine .25%, to patients who receive bupivacaine .25% with epinephrine 1:200,000.

After cesarean delivery, all groups will actively control the use of post-operative pain medication by indicating to the care nurse whether or not pain medication is desired. Pain control for all groups will be the standard pain treatment: ibuprofen for mild to moderate pain and percocet (oxycodone) for severe pain.

The U.S. Food and Drug Administration (FDA) has approved bupivicaine as an anesthetic and for pain but the FDA has not approved bupivicaine to be given specifically for postoperative cesarean pain. Acetaminophen, oxycodone and ibuprofen are being used as part of routine clinical care for pain control after cesarean. Fentanyl and duramorph are being used in spinal anesthesia and are FDA approved for regional anesthesia and used for this purpose in routine clinical care.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine/ Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• elective cesarean delivery
• planned spinal anesthesia

Exclusion criteria:

• Non-English speaking
• Urgent or emergent cesarean delivery
• Active labor [defined as: >4cm cervical dilation or regular contractions noted on tocometer (>2 contractions in a 10 minute period for 30 consecutive minutes)]
• Chronic antepartum opioid use
• History of substance abuse (alcohol or drug)
• Current tobacco use
• Chronic steroid use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine 0.25%; standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%	Drug: Bupivacaine; 20 ml subcutaneous bupivacaine (Marcaine) 0.25%. Bupivacaine is an anesthetic which can numb an area of the body to relieve pain during surgery or medical procedures, childbirth, and dental work.; Other Names: Marcaine; Drug: Morphine; intrathecal morphine (Duramorph) 150mcg. DURAMORPH (morphine injection) is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. DURAMORPH (morphine injection) administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function.; Other Names: Duramorph; Drug: Fentanyl; intrathecal fentanyl 10 mcg. Fentanyl (also spelled fentanil) is an opioid which is used as a pain medication and together with other medications for anesthesia.; Other Names: Opioid
Active Comparator: bupivacaine 0.25% + epinephrine; standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine	Drug: Bupivacaine; 20 ml subcutaneous bupivacaine (Marcaine) 0.25%. Bupivacaine is an anesthetic which can numb an area of the body to relieve pain during surgery or medical procedures, childbirth, and dental work.; Other Names: Marcaine; Drug: Morphine; intrathecal morphine (Duramorph) 150mcg. DURAMORPH (morphine injection) is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. DURAMORPH (morphine injection) administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function.; Other Names: Duramorph; Drug: Fentanyl; intrathecal fentanyl 10 mcg. Fentanyl (also spelled fentanil) is an opioid which is used as a pain medication and together with other medications for anesthesia.; Other Names: Opioid; Drug: Epinephrine; Epinephrine injection is used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Epinephrine is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing the muscles in the airways and tightening the blood vessels.; Other Names: Adrenaline
Placebo Comparator: Saline Solution; standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)	Drug: Bupivacaine; 20 ml subcutaneous bupivacaine (Marcaine) 0.25%. Bupivacaine is an anesthetic which can numb an area of the body to relieve pain during surgery or medical procedures, childbirth, and dental work.; Other Names: Marcaine; Drug: Morphine; intrathecal morphine (Duramorph) 150mcg. DURAMORPH (morphine injection) is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. DURAMORPH (morphine injection) administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function.; Other Names: Duramorph; Drug: Fentanyl; intrathecal fentanyl 10 mcg. Fentanyl (also spelled fentanil) is an opioid which is used as a pain medication and together with other medications for anesthesia.; Other Names: Opioid; Other: Saline solution; 20 ml subcutaneous NACL 0.9% - saline solution is the placebo; Other Names: Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Supplemental Oxycodone Used	Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record	4-24 hours post operative

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Jeffrey Bernstein, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): August 17, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Referred; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Fentanyl; Bupivacaine; Morphine; Epinephrine
• Other Study ID Numbers: 2017-8094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes