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

NCT03383588 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017-8094
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Referred

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

bupivacaine 0.25%

ACTIVE COMPARATOR

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; Drug: Morphine; Drug: Fentanyl

bupivacaine 0.25% + epinephrine

ACTIVE COMPARATOR

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; Drug: Morphine; Drug: Fentanyl; Drug: Epinephrine

Saline Solution

PLACEBO COMPARATOR

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; Drug: Morphine; Drug: Fentanyl; Other: Saline solution

Interventions

Bupivacaine DRUG

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.

Also known as: Marcaine

Saline Solution; bupivacaine 0.25%; bupivacaine 0.25% + epinephrine

Morphine DRUG

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.

Also known as: Duramorph

Saline Solution; bupivacaine 0.25%; bupivacaine 0.25% + epinephrine

Fentanyl DRUG

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.

Also known as: Opioid

Saline Solution; bupivacaine 0.25%; bupivacaine 0.25% + epinephrine

Epinephrine DRUG

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.

Also known as: Adrenaline

bupivacaine 0.25% + epinephrine

Saline solution OTHER

20 ml subcutaneous NACL 0.9% - saline solution is the placebo

Also known as: Sodium Chloride

Saline Solution

Eligibility Criteria

• Age: 17 Years - 40 Years
• Gender Eligibility Details: Pregnant women undergoing Cesarean Section under spinal anesthesia
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• elective cesarean delivery
• planned spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Albert Einstein College of Medicine/ Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Pain, Referred

Interventions

Bupivacaine; Morphine; Fentanyl; Analgesics, Opioid; Epinephrine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects and Technical problems with measurement leading to unreliable or uninterpretable data; Study terminated early secondary to similar study published showing no difference in outcomes

Results Point of Contact

• Title: Dr Catherine Igel
• Organization: Montefiore Medical Center

cigel@montefiore.org

718-405-8200

Study Officials

• Jeffrey Bernstein, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 26, 2017
• Study Start: July 19, 2018
• Primary Completion: August 17, 2018
• Study Completion: December 31, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)