Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: Placebo
Normal saline will be infiltrated
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placebo injection in the Pfannenstiel incision
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Comparatore attivo: Intervention
Liposomal bupivacaine will be infiltrated
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liposomal bupivacaine injection in the Pfannenstiel incision
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Score With Activity
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Score With Activity
Lasso di tempo: 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)
Lasso di tempo: 72-hours post-operatively
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Total opioid use (in morphine equivalents)
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72-hours post-operatively
|
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Satisfaction With Post-operative Pain Control
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: William H Barth, Jr, MD, Massachusetts General Hospital
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2016P002307/MGH
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Prove cliniche su Dolore, Postoperatorio
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University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team