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

Montefiore Medicine Academic Health System

Status and phase: Terminated; Phase 2

Conditions: Pain, Referred

Treatments: Other: Saline solution; Drug: Fentanyl; Drug: Bupivacaine; Drug: Morphine; Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03383588

2017-8094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 17 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 3 patient groups, including a placebo group

bupivacaine 0.25%

Active Comparator group

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%

Treatment:

Drug: Morphine

Drug: Bupivacaine

Drug: Fentanyl

bupivacaine 0.25% + epinephrine

Active Comparator group

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

Treatment:

Drug: Epinephrine

Drug: Morphine

Drug: Bupivacaine

Drug: Fentanyl

Saline Solution

Placebo Comparator group

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)

Treatment:

Drug: Morphine

Drug: Bupivacaine

Drug: Fentanyl

Other: Saline solution