A Phase 2 interventional study of Bupivacaine and Morphine in Pain, Referred, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to female participants aged 17 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Montefiore Medical Center · Phase 2, Interventional, and Supportive care
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.
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.
Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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
20 ml subcutaneous NACL 0.9% - saline solution is the placebo
Also known as: Sodium Chloride
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
| Milestone | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution |
|---|---|---|---|
| Started | 8 | 9 | 9 |
| Completed | 8 | 9 | 9 |
| Not completed | 0 | 0 | 0 |
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
| mg of supplemental oxycodone | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution |
|---|---|---|---|
| Amount of Supplemental Oxycodone Used | 19 (10 to 30) | 25 (15 to 40) | 23 (10 to 40) |
Collected over The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupivacaine 0.25% | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) |
| Bupivacaine 0.25% + Epinephrine | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) |
| Saline Solution | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) |
| Event | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution |
|---|---|---|---|
| Postpartum readmission to hospital (OBGYN related)Pregnancy, puerperium and perinatal conditions | 1/8 | 0/9 | 0/9 |
| Large intraoperative blood lossPregnancy, puerperium and perinatal conditions | 0/8 | 0/9 | 1/9 |
| Postpartum re-admission to hospital (not OBGYN related)Hepatobiliary disorders | 0/8 | 1/9 | 0/9 |
| Large intraoperative blood lossPregnancy, puerperium and perinatal conditions | 0/8 | 1/9 | 0/9 |
| Large intraoperative blood lossPregnancy, puerperium and perinatal conditions | 0/8 | 0/9 | 1/9 |
baseline population presenting for scheduled c-section; study terminated early secondary to other similar published study showing no difference
| Age, Continuous(years) | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution | Total |
|---|---|---|---|---|
| Mean | 29 (23 to 35) | 34 (28 to 40) | 29 (27 to 37) | 31 (23 to 40) |
| Sex: Female, Male(Participants) | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution | Total |
|---|---|---|---|---|
| Female | 8 | 9 | 9 | 26 |
| Male | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 3 | 4 |
| White | 1 | 1 | 0 | 2 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 6 | 5 | 17 |
| Region of Enrollment(Participants) | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution | Total |
|---|---|---|---|---|
| United States | 8 | 9 | 9 | 26 |
| Estimated Blood Loss (EBL)(ml of blood) | Bupivacaine 0.25% | Bupivacaine 0.25% + Epinephrine | Saline Solution | Total |
|---|---|---|---|---|
| Mean | 900 (400 to 2000) | 855 (500 to 1200) | 744 (600 to 1200) | 830 (400 to 2000) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Aug 2018, 0 months.
Results were first posted in Jan 2020, 1 year 4 months after primary completion.
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This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epinephrine
Pain, Referred