Pain, Referred
Conditions
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.
Interventions
DRUGBupivacaine
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.
DRUGMorphine
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.
DRUGFentanyl
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.
DRUGEpinephrine
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.
OTHERSaline solution
20 ml subcutaneous NACL 0.9% - saline solution is the placebo
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Supplemental Oxycodone Used | 4-24 hours post operative | Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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% | 8 |
| 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 | 9 |
| 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) | 9 |
| Total | 26 |
Baseline characteristics
| Characteristic | Bupivacaine 0.25% + Epinephrine | Saline Solution | Bupivacaine 0.25% | Total |
|---|---|---|---|---|
| Age, Continuous | 34 years | 29 years | 29 years | 31 years |
| Estimated Blood Loss (EBL) | 855 ml of blood | 744 ml of blood | 900 ml of blood | 830 ml of blood |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 5 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 9 Participants | 9 Participants | 8 Participants | 26 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 8 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 1 / 8 | 2 / 9 | 2 / 9 |
Outcome results
Primary
Amount of Supplemental Oxycodone Used
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
Time frame: 4-24 hours post operative
Population: all patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivacaine 0.25% | Amount of Supplemental Oxycodone Used | 19 mg of supplemental oxycodone |
| Bupivacaine 0.25% + Epinephrine | Amount of Supplemental Oxycodone Used | 25 mg of supplemental oxycodone |
| Saline Solution | Amount of Supplemental Oxycodone Used | 23 mg of supplemental oxycodone |