Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Multimodal Pain Management for Cesarean Delivery

1 décembre 2021 mis à jour par: The University of Texas Medical Branch, Galveston

Multimodal Pain Management for Cesarean Delivery: A Randomized Control Trial

Opioid use and abuse has become a major medical problem in the United States. Over prescription of opioid medications is a major contributor to this growing problem. Cesarean delivery (CD) is the most commonly performed surgery in the US and women are generally given opioid medications for postoperative pain management. This is not a common practice in other developed countries. We believe that a multimodal pain management strategy is superior to current practices for control of postoperative pain after CD and will lead to a decrease in the use of opioid medications. This will have beneficial effects on patients' recovery and bonding with their newborns, as well as societal effects in reducing the burden of opioid abuse in the US. Our objective is to investigate the use of a multimodal pain regimen in pregnant patients undergoing CD. This is a randomized double-blinded, placebo controlled trial. The multimodal intervention consists of a pre-operative dose of IV acetaminophen (Ofirmev), infiltration of subcutaneous bupivacaine prior to skin incision, and a dose of IM ketorolac at time of fascial closure. These study medications are currently used in our patient population but not in a standardized fashion, not in every patient, and not always in combination with each other. The control group will receive placebo IV infusion preoperatively and an IM injection at fascial closure, and subcutaneous infiltration with normal saline before skin incision. Both groups will receive spinal regional anesthesia as per anesthesia team and then postoperatively, both groups will receive the current standard of care, which consists postoperative hydrocodone/acetaminophen and ibuprofen as needed depending on pain score. Our primary outcome of interest will be the total opioid intake in the first 48 hours after surgery. Secondary outcomes include time to first opioid given, pain scores at 6-12, 24 and 48 hours post op, and total number of opioid tablets left after discharge on post op day number 7. We will also evaluate patient satisfaction scores and total length of hospital stay. We will evaluate neonatal outcomes including Apgar scores, cord blood gases, immediate newborn complications in the first 48 hours after birth, and any infant adverse outcomes related to maternal opioid use up to 4 weeks of life. Our hypothesis is that our multimodal pain regimen will decrease the total opioid requirement in the first 48 hours after surgery.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

We are proposing a double-blinded, placebo controlled, randomized trial of patients undergoing elective cesarean delivery. Participants will be randomized to either a control group or study group. This is a double-blinded study, neither participants nor the obstetric or anesthesia team are aware of study assignment. The study group, aka multimodal group, will receive 1 g of IV acetaminophen (ofirmev) within 30 minutes before starting the surgery, regional anesthesia (spinal anesthesia only) with fentanyl, duramorph (morphine) and bupivacaine will be performed as per anesthesia team, the anticipated sight of skin incision will be infiltrated with 20 mL of bupivacaine 0.25% in the subcutaneous space prior to skin incision, and 60 mg of intramuscular (IM) ketorolac (toradol) will be given at the time of fascial closure. The control group will receive a placebo drip within 30 minutes before starting the surgery, regional anesthesia (spinal anesthesia only) with fentanyl, duramorph (morphine) and bupivacaine will be performed as per anesthesia team, the anticipated sight of skin incision will be infiltrated with 20 mL of normal saline in the subcutaneous space prior to skin incision, and an IM dose of placebo at the time of fascial closure. Post-operatively both groups will be managed similarly.

Inclusion Criteria:

  • Women who are 18 - 45 years of age at the time of cesarean delivery with the ability to give informed consent
  • Elective cesarean delivery
  • Gestational age ≥ 34 weeks
  • Fluent in either English or Spanish
  • Spinal anesthesia

Exclusion Criteria:

Urgent or emergent CD Active labor Epidural or Intrathecal regional anesthesia General anesthesia Patients with a contraindication for regional anesthesia Acute or chronic hepatic disease Acute or chronic renal disease Active asthma Gastrointestinal ulceration Inflammatory bowel disease Allergy to ketorolac, acetaminophen, hydrocodone, codeine, ibuprofen or bupivacaine Opioid dependence Non reassuring fetal or maternal status requiring immediate delivery Placenta previa or accreta Acute or chronic pain disorder Maternal weight <50 kilograms Uncontrolled hypertension Ischemic cardiac disease Congestive heart failure Thrombocytopenia, platelet count <150,000/microliter Preeclampsia including Hemolysis Elevated Liver enzymes Low Platelets syndrome DIC or active hemorrhage before randomization Estimated blood loss > 2000 mL

Primary Outcome: The primary outcome of the study is the total opioid (hydrocodone) use in milligrams in the first 48 hours after cesarean delivery.

Type d'étude

Interventionnel

Inscription (Réel)

120

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Galveston, Texas, États-Unis, 77555
        • University of Texas Medical Branch

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Women who are 18 - 45 years of age at the time of cesarean delivery with the ability to give informed consent
  • Elective cesarean delivery
  • Gestational age ≥ 34 weeks
  • Fluent in either English or Spanish
  • Spinal anesthesia

Exclusion Criteria:

  • Urgent or emergent CD
  • Epidural or combined spinal epidural regional anesthesia
  • General anesthesia
  • Patients with a contraindication for regional anesthesia
  • Acute or chronic hepatic disease
  • Acute or chronic renal disease
  • Active asthma
  • Gastrointestinal ulceration
  • Inflammatory bowel disease
  • Allergy to ketorolac, acetaminophen, hydrocodone, codeine, ibuprofen or bupivacaine
  • Opioid dependence
  • Non reassuring fetal or maternal status requiring immediate delivery
  • Placenta previa or accreta
  • Acute or chronic pain disorder
  • Maternal weight <50 kilograms
  • Uncontrolled hypertension
  • Ischemic cardiac disease
  • Congestive heart failure
  • Thrombocytopenia, platelet count <150,000/microliter
  • Preeclampsia including Hemolysis Elevated Liver enzymes Low Platelets syndrome
  • Disseminated intravascular coagulation (DIC) or active hemorrhage before randomization
  • Estimated blood loss > 2000 mL

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo Control Group
Patients will receive a placebo dose of all three study medications: Patients will receive the pre-operative dose of IV normal saline placebo within 30 minutes of going to the OR for CD. The patient will receive the subcutaneous infiltration of 20 mL of subcutaneous normal saline placebo after positioning and preparation but prior to skin incision. At the time of fascial closure, the patient will receive an IM dose of normal saline placebo.
Médicament: Normal saline
Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.
Comparateur actif: Multimodal Pain Regimen Group
Patients will receive the actual study medication for all three study medications: Patients will receive the pre-operative dose of IV acetaminophen 1 g within 30 minutes of going to the OR for CD. The patient will receive the subcutaneous infiltration of either 20 mL of bupivacaine 0.25% after positioning and preparation but prior to skin incision. At the time of fascial closure, the patient will receive 60 mg of IM ketorolac.
Médicament: Intravenous acetominophen
One dose if 1 gram intravenous to be given pre-surgery
Autres noms:
  • Ofirmev
Médicament: Ketorolac, intramuscular
One dose of 60 mg Intramuscular to be given at time of skin closure
Autres noms:
  • Toradol
Médicament: Bupivacaine, subcutaneous
Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)
Délai: 48 hours post cesarean delivery
Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents
48 hours post cesarean delivery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to First Administration of Opioid Pain Medication Post Operatively
Délai: 48 hours post cesarean delivery
Time, in hours, to first administration of opioid pain medication post operatively
48 hours post cesarean delivery
Pain Score at 6-12 Hours Post Operatively
Délai: 6-12 hours post-operatively
Pain score at 6-12 hours post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).
6-12 hours post-operatively
Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.
Délai: 7 days post delivery
Number of opioid pain tablets remaining on post-operative day #7 from hospital discharge as reported by patients
7 days post delivery
Hospital Length of Stay
Délai: From time of hospital admission to time of discharge home up to 168 hours.
Time to discharge from hospital, measured in hours
From time of hospital admission to time of discharge home up to 168 hours.
Pain Score at 24 Hours Post-operatively
Délai: 24 hours post-operatively
Pain Score at 24 Hours Post Operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).
24 hours post-operatively
Pain Score at 48 Hours Post-operatively
Délai: 48 hours post-operatively
Pain Score at 48 Hours Post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).
48 hours post-operatively
Apgar Score at 5 Minutes
Délai: 5 minutes after birth
This is the Apgar score of the newborn collected at 5 minutes. Range is from 0-10, with the higher scores meaning a better outcome.
5 minutes after birth
NICU Admission
Délai: after birth and before hospital discharge
Rate of admission to the neonatal intensive care unit
after birth and before hospital discharge
Need for Respiratory Support
Délai: after birth and before hospital discharge
neonate receipt of oxygen by nasal cannula or mechanical ventilation
after birth and before hospital discharge

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The University of Texas Medical Branch, Galveston

Les enquêteurs

  • Chercheur principal: Emily E Hadley, MD, University of Texas

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2016

Achèvement primaire (Réel)

1 juin 2017

Achèvement de l'étude (Réel)

1 juillet 2017

Dates d'inscription aux études

Première soumission

29 septembre 2016

Première soumission répondant aux critères de contrôle qualité

30 septembre 2016

Première publication (Estimation)

4 octobre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 décembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 décembre 2021

Dernière vérification

1 octobre 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB 16-0121

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur La douleur

Essais cliniques sur Normal saline

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Hong Kong

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner