Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study is a randomized controlled trial. A total of 80 patients will be randomized 1:1 to intervention (liposomal bupivacaine) versus control (placebo solution).
The planned intervention is the infiltration of liposomal bupivacaine (or control) at the time of fascial closure at a Pfannenstiel incision, after the delivery of the infant and repair of the hysterotomy. The procedure to instill the drug is as follows: Once the patient is in the operating room, neuraxial anesthesia will be administered per routine practice. A Pfannenstiel skin incision will be made. The usual cesarean delivery procedure will be performed at the discretion of the surgeon. Once the surgical team is about to begin fascial closure, the study drug will then be infiltrated by a member of the study team, with 50% of the study solution in subcutaneous space and 50% in the fascial plane, taking care to evenly spread the drug in the superior and inferior aspects of the incision. For the fascial infiltration, liposomal bupivacaine will be preferentially infiltrated laterally. The remainder of the cesarean delivery will proceed according to the usual fashion. At any point in the cesarean delivery, the surgeon may chose to administer or withhold ketorolac.
Post-operative pain management will be: intrathecal morphine, scheduled ketorolac 30mg IV x 24h followed by ibuprofen 600mg q6h x 24h, scheduled Tylenol 650mg q6h x 48h, and prn oxycodone 5-10mg q4h. This is the current pain management protocol for postoperative women after cesarean delivery. If Tylenol or NSAIDs are contraindicated, either due to the discretion of the clinical team or pre-existing patient contraindication, these will not be administered but are not a reason for study exclusion.
The investigators plan to enroll 80 patients into this pilot study, 40 per group. This sample size is based on prior data among women who had a cesarean delivery at this institution, and were asked to report their pain scores with activity at 48- and 72- hours after operation. With this sample size, the investigators have 80% power to detect a 1.5 point difference in pain at 48 hours, and 90% power to detect a 1.5 point difference in pain at 72 hours, and account for any protocol violations or loss to follow-up.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Scheduled cesarean delivery via Pfannenstiel incision;
- Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.
Exclusion Criteria:
- Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
- Contraindication to neuraxial anesthetic;
- Allergy to local anesthetic;
- Planned general anesthetic.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Placebo
Normal saline will be infiltrated
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placebo injection in the Pfannenstiel incision
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Actieve vergelijker: Intervention
Liposomal bupivacaine will be infiltrated
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liposomal bupivacaine injection in the Pfannenstiel incision
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain Score With Activity
Tijdsspanne: at 48-hours post-operatively
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Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39 |
at 48-hours post-operatively
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain Score With Activity
Tijdsspanne: at 72 -hours post-operatively
|
Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment |
at 72 -hours post-operatively
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|
Total Opioid Use (in Morphine Equivalents)
Tijdsspanne: 72-hours post-operatively
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Total opioid use (in morphine equivalents)
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72-hours post-operatively
|
|
Satisfaction With Post-operative Pain Control
Tijdsspanne: 48-hours post-operatively
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PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied
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48-hours post-operatively
|
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Postoperative Hospital Length of Stay
Tijdsspanne: 0 to 96 hours postoperatively
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Postoperative hospital length of stay
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0 to 96 hours postoperatively
|
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Number of Patients With Wound Complication - Separation, Dehiscence, Infection
Tijdsspanne: 14 days postoperatively
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Wound complication - separation, dehiscence, infection
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14 days postoperatively
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Number of Patients With Allergic Reaction Attributable to Local Anesthestic
Tijdsspanne: 0-96 hours postoperatively
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incisional rash, hives, anaphylaxis
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0-96 hours postoperatively
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Operative Time of Cesarean Delivery
Tijdsspanne: Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
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Operative time of cesarean delivery
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Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
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Patient Satisfaction With Pain Management at 6w Postpartum
Tijdsspanne: 6 weeks postpartum
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Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used
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6 weeks postpartum
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: William H Barth, Jr, MD, Massachusetts General Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2016P002307/MGH
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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