Pain, PostoperativePhase 2NCT03545516
Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery
A Phase 2 study testing Bupivacaine and Dexmedetomidine in people with Pain, Postoperative and Anesthesia, Local, run by Richmond University Medical Center at 1 site in United States.
Trial summary
This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Local, Opioid Use
- What is being tested?
- Bupivacaine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 1 Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All scheduled Cesarean deliveries with intrathecal or epidural anesthesia
Who cannot join
- Emergency Cesarean deliveries
- Multifetal gestation
- Subjects <18 years old
- Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)
- Cesarean delivery with general anesthesia
- Known allergy or hypersensitivity to any of the study medications
- Subjects that can't comprehend the visual analog scale for quantitative pain assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond University Medical Center
Staten Island, New York, 10310
About this study
Official title: Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery
This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.
Read the detailed description
The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.
- Conditions
- Pain, Postoperative, Anesthesia, Local, Opioid Use
- Being tested
- Bupivacaine, Dexmedetomidine, Placebo
- Keywords
- Wound infiltration, Post Cesarean, Pain management, bupivacaine, dexmedetomidine, postoperative pain
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Bupivacaine wound infiltration
Injection of bupivacaine into the surgical incision prior to its closure.
DexmedetomidineDrug
Also called Dexmedetomidine wound infiltration
Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
PlaceboDrug
Injection of a placebo into the surgical wound
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Wound infiltration with a placebo Receives: Drug: Placebo |
| Bupivacaine | Experimental | Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL Receives: Drug: Bupivacaine |
| Bupivacaine and Dexmedetomidine | Experimental | Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution . Receives: Drug: Bupivacaine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of opioid free Cesarean deliveries
Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course
Measured: 1 year
Secondary outcomes (6)
Time to first rescue analgesia
Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered
Measured: 0 hour post-cesarean to time rescue analgeisa is administered]
Total opioid consumption
Measure the subjects total opioid consumption for the total duration of the postoperative course.
Measured: 0-14 days
Side effects/Adverse reactions
Measure any side effects/allergic reactions attributed to use of any of the study drugs.
Measured: 0-14 days
Postoperative hospital stay
Measure the length of the post-operative hospital stay .
Measured: 0-14days
Complications from procedures
Measure any complications associated with the wound infiltration procedure
Measured: 0-14 days
Breast feeding capacity
Assess the subject's capacity to breast feed during the postoperative course
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start17 Sep 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richmond University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisha Lakhi, MD, Richmond University Medical Center
- Investigators
- Nisha Lakhi, MD, Principal investigator, Richmond University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545516
- Sponsor's protocol ID
- Post Cesarean Pain Management
- Status last verified
- Aug 2018
- First submitted
- 22 Mar 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03545516
- Acronym / sponsor ID
- Post Cesarean Pain Management
- Conditions
- Pain, Postoperative, Anesthesia, Local, Opioid Use
- Keywords
- Wound infiltration, Post Cesarean, Pain management, bupivacaine, dexmedetomidine, postoperative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Richmond University Medical CenterUniversity, hospital or other
- Study start
- 17 Sep 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.
Detailed description
The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboWound infiltration with a placebo |
| Bupivacaine | Experimental | Drug: BupivacaineWound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL |
| Bupivacaine and Dexmedetomidine | Experimental | Drug: Bupivacaine, Drug: DexmedetomidineWound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All scheduled Cesarean deliveries with intrathecal or epidural anesthesia
Key exclusion criteria (7 listed)
- Emergency Cesarean deliveries
- Multifetal gestation
- Subjects <18 years old
- Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)
- Cesarean delivery with general anesthesia
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: Bupivacaine wound infiltrationInjection of bupivacaine into the surgical incision prior to its closure. | Drug | Bupivacaine, Bupivacaine and Dexmedetomidine |
| DexmedetomidineAlso: Dexmedetomidine wound infiltrationInjection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure. | Drug | Bupivacaine and Dexmedetomidine |
| PlaceboInjection of a placebo into the surgical wound | Drug | Placebo |
Primary outcome
Total number of opioid free Cesarean deliveries
Time frame: 1 year
Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course
6 secondary outcomes
Time to first rescue analgesia
Time frame: 0 hour post-cesarean to time rescue analgeisa is administered]
Total opioid consumption
Time frame: 0-14 days
Side effects/Adverse reactions
Time frame: 0-14 days
Postoperative hospital stay
Time frame: 0-14days
Complications from procedures
Time frame: 0-14 days
Breast feeding capacity
Time frame: 0-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- 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.
Nisha Lakhi, MD principal investigator
Richmond University 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 and Dexmedetomidine in people with Pain, Postoperative and Anesthesia, Local, run by Richmond University 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 1 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nisha Lakhi, MD (718-818-2109, NLAKHI@RUMCSI.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of opioid free Cesarean deliveries (time frame: 1 year). 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 29 Aug 2018.