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

Primary Purpose

Pain, Referred

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Morphine
Fentanyl
Epinephrine
Saline solution
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Referred

Eligibility Criteria

17 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine/ Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

bupivacaine 0.25%

bupivacaine 0.25% + epinephrine

Saline Solution

Arm Description

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%

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

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)

Outcomes

Primary Outcome Measures

Amount of Supplemental Oxycodone Used
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
December 23, 2019
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03383588
Brief Title
Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section
Official Title
Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
study was published during initial recruitment that showed no difference
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Referred

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bupivacaine 0.25%
Arm Type
Active Comparator
Arm Description
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%
Arm Title
bupivacaine 0.25% + epinephrine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Saline Solution
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Duramorph
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Opioid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
Adrenaline
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline solution
Other Intervention Name(s)
Sodium Chloride
Intervention Description
20 ml subcutaneous NACL 0.9% - saline solution is the placebo
Primary Outcome Measure Information:
Title
Amount of Supplemental Oxycodone Used
Description
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
Time Frame
4-24 hours post operative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women undergoing Cesarean Section under spinal anesthesia
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bernstein, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine/ Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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