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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03383588
Other study ID # 2017-8094
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 19, 2018
Est. completion date December 31, 2018

Study information

Verified date December 2019
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date December 31, 2018
Est. primary completion date August 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Albert Einstein College of Medicine/ Montefiore Medical Center Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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