Pain, ReferredPhase 2NCT03383588
Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section
A Phase 2 study testing Bupivacaine, Morphine and Fentanyl in people with Pain, Referred, run by Montefiore Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Referred
- What is being tested?
- Bupivacaine, Morphine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 31 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- elective cesarean delivery
- planned spinal anesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine/ Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Pain, Referred
- Being tested
- Bupivacaine, Morphine, Fentanyl, Epinephrine, Saline solution
- Medical subject headings
- Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
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.
MorphineDrug
Also called Duramorph
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.
FentanylDrug
Also called Opioid
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.
EpinephrineDrug
Also called Adrenaline
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.
Saline solutionOther
Also called Sodium Chloride
20 ml subcutaneous NACL 0.9% - saline solution is the placebo
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: 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 Receives: 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) Receives: Drug: Bupivacaine; Drug: Morphine; Drug: Fentanyl; Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Supplemental Oxycodone Used
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
Measured: 4-24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start19 Jul 2018
- Primary completion17 Aug 2018
- Study completion31 Dec 2018
Why it stopped: study was published during initial recruitment that showed no difference
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ReferredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Bernstein, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383588
- Sponsor's protocol ID
- 2017-8094
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2017
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03383588
- Acronym / sponsor ID
- 2017-8094
- Conditions
- Pain, Referred
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study was published during initial recruitment that showed no difference
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupivacaine 0.25% | Active comparator | Drug: Bupivacaine, Drug: Morphine, Drug: Fentanylstandard 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% |
| bupivacaine 0.25% + epinephrine | Active comparator | Drug: Bupivacaine, Drug: Morphine, Drug: Fentanyl, Drug: Epinephrinestandard 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 |
| Saline Solution | Placebo comparator | Drug: Bupivacaine, Drug: Morphine, Drug: Fentanyl, Other: Saline solutionstandard 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) |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- elective cesarean delivery
- planned spinal anesthesia
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: Marcaine20 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. | Drug | Saline Solution, bupivacaine 0.25%, bupivacaine 0.25% + epinephrine |
| MorphineAlso: Duramorphintrathecal 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. | Drug | Saline Solution, bupivacaine 0.25%, bupivacaine 0.25% + epinephrine |
| FentanylAlso: Opioidintrathecal fentanyl 10 mcg. Fentanyl (also spelled fentanil) is an opioid which is used as a pain medication and together with other medications for anesthesia. | Drug | Saline Solution, bupivacaine 0.25%, bupivacaine 0.25% + epinephrine |
| EpinephrineAlso: AdrenalineEpinephrine 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. | Drug | bupivacaine 0.25% + epinephrine |
| Saline solutionAlso: Sodium Chloride20 ml subcutaneous NACL 0.9% - saline solution is the placebo | Other | Saline Solution |
Primary outcome
Amount of Supplemental Oxycodone Used
Time frame: 4-24 hours post operative
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Bernstein, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine, Morphine and Fentanyl in people with Pain, Referred, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Supplemental Oxycodone Used (time frame: 4-24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.