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Liposomal Bupivacaine + Bupivacaine vs. Bupivacaine Alone on Opioid Use After Elective c/Section

Primary Purpose

Postoperative Pain, Cesarean Section

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine HCl
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative analgesia, Postoperative opioid use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females 18 years of age and older at screening
  • Subjects at 37 completed weeks of gestation or greater undergoing elective primary or repeat cesarean delivery (CD)
  • Pfannenstiel incision
  • Regional spinal anesthesia
  • ASA classification I, II, or III
  • Able to give informed consent
  • English- or Spanish-speaking

Exclusion Criteria:

  • ASA classification IV
  • Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia).
  • Potential drug interaction(s) with bupivacaine
  • Severe renal or hepatic dysfunction manifest as serum creatinine level >2 mg/dL, blood urea nitrogen level >50 mg/dL , serum aspartate aminotransferase level >3 times the upper limit of normal, or serum alanine aminotransferase level >3 times the ULN.
  • Any clinically significant maternal or fetal event or condition arising during surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course. In this situation, the subject would be ineligible to receive study drug and withdrawn from the study.
  • Chronic pain disorder manifest as a concurrent, painful, physical condition that may require long-term, consistent use of opioids postoperatively for pain that is not strictly related to the surgery and may confound postsurgical assessments.
  • History of, suspected, or known addiction or abuse of illicit drug(s) or prescription medication(s) within the past 2 years.
  • Planned concurrent surgical procedure except for salpingo-oophorectomy or tubal ligation.
  • Subject at increased risk for bleeding or coagulation disorder (defined as platelet count less than 80,000/mm3 or international normalized ratio[INR] greater than 1.5).
  • Pregnancy body mass index >50 kg/m2 or otherwise not anatomically appropriate to undergo local incision infiltration.
  • Conversion of spinal anesthesia to general anesthesia due to incomplete neuraxial block and unsatisfactory surgical anesthesia.

Sites / Locations

  • Atrium Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal Bupivacaine + Bupivacaine HCL

Bupivacaine HCl surgical-site incision infiltration

Arm Description

Liposomal bupivacaine + bupivacaine HCl surgical-site incision infiltration following spinal anesthesia

Bupivacaine HCl surgical-site incision infiltration following spinal anesthesia

Outcomes

Primary Outcome Measures

Amount of total opioid MME (milligram morphine equivalents) consumed at 24, 48 and 72hrs post-op
3.1 To compare total opioid consumption through 72-hours following EXPAREL® + bupivacaine HCl surgical-site infiltration versus bupivacaine HCl alone at elective primary or repeat cesarean delivery after spinal anesthesia. 3.2 Primary outcome of this study is total opioid consumption measured in milligram morphine equivalents (MME) at 24-, 48- and 72-hours postoperatively and total MME for duration of hospital admission.

Secondary Outcome Measures

time to initial rescue analgesia administration
Time in hours and minutes
Numeric Pain Rating Score at 72 hours Postoperative
postoperative pain assessment with NRS (Numeric Pain Rating Score). NRS score is comprised of 4 pain questions with the patient rating each one on a scale of 0(no pain) to 10(worst pain imaginable). Lower scores are favorable.
Overall Benefit of Analgesia Score at 72 hours Postoperative
postoperative pain assessment with OBAS (Overall Benefit of Analgesia Score). The OBAS is comprised of 7 questions each being scored by the patient from 0(minimal pain) to 4(maximum imaginable pain). Each question is then added up to total the overall benefit of analgesia score. Lower scores are favorable.
Length of hospital stay
measured in days and hours
Initiation of breastfeeding
yes/no and time to initiation as measured in days and hours
Postpartum depression scores
PHQ-9 postpartum depression scores. Possible range is 0-27. Lower scores mean less depression.

Full Information

First Posted
November 19, 2019
Last Updated
April 20, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04232306
Brief Title
Liposomal Bupivacaine + Bupivacaine vs. Bupivacaine Alone on Opioid Use After Elective c/Section
Official Title
The Effect of Liposomal Bupivacaine Plus Bupivacaine Versus Bupivacaine Alone on Postoperative Opioid Use After Elective Cesarean Delivery: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of local wound infiltration of EXPAREL® (liposomal bupivacaine) with bupivacaine HCl compared to active control with bupivacaine HCl alone following elective primary or repeat cesarean delivery with spinal anesthesia.
Detailed Description
Pain in the postpartum period is an important concern of new mothers. With over one-third of deliveries ending in cesarean section, effective postoperative pain control is essential in the care of postpartum patients.1 Improved pain control in the postpartum period after cesarean delivery (CD) is associated with improved overall maternal health and satisfaction, decreased postpartum depression, shortened hospital stay, decreased opioid consumption, and decreased healthcare costs, as well as possible facilitation of early contact of mothers with their infants.2 Pain control is of great concern to women during and after cesarean delivery.3 Pain relief and patient satisfaction are inadequate in many cases. Pain may be severe, last at least 48-72 hours, and may impair early postoperative recovery. Opioids are primarily used in the post-operative period. Although opioids are safe to use in breastfeeding mothers, they are not without unwanted side effects.4 Local anesthetics and parenteral NSAIDs are also beneficial adjuncts to regional or general anesthesia after CD by reducing opioid consumption and improving pain relief.5 In addition, field block with wound infiltration with local anesthetic is an effective and safe adjunct for pain control. Previous studies have shown improved postoperative pain control with TAP (transversus abdominis plane) blocks with bupivacaine in hysterectomy patients.4 Another study has looked at the effects of bupivacaine-soaked spongostan placed in cesarean wounds.2 EXPAREL®® (Parsippany, NJ: Pacira Pharmaceuticals, Inc) is a liposomal form of bupivacaine. Its mechanism of action is by DepoFoam® technology, in which microscopic, polyhedral molecules that contain aqueous chambers with liposomal bupivacaine that are slowly released over hours to days with erosion and rearrangement of lipid membranes.6 The slow release of local anesthetic extends its pharmacologic effect and provides longer postsurgical pain control for up to 72 hours.6 This method of delivery of local anesthetic has the potential to decrease postoperative opioid consumption.7 EXPAREL® is an FDA-approved medication for the general use of postoperative surgical site pain control. Paracervical block is the only obstetric contraindication to EXPAREL® use. The purpose of this study is to compare the effectiveness of local wound infiltration of EXPAREL® (liposomal bupivacaine) with bupivacaine HCl compared to active control with bupivacaine HCl alone following elective primary or repeat cesarean delivery with spinal anesthesia. The investigators hypothesize that narcotic use during postoperative hospitalization will be decreased using liposomal bupivacaine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cesarean Section
Keywords
Postoperative analgesia, Postoperative opioid use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, single-blind, active-controlled trial
Masking
Participant
Masking Description
Patients will be blinded to treatment arm to which patients are assigned.
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine + Bupivacaine HCL
Arm Type
Experimental
Arm Description
Liposomal bupivacaine + bupivacaine HCl surgical-site incision infiltration following spinal anesthesia
Arm Title
Bupivacaine HCl surgical-site incision infiltration
Arm Type
Active Comparator
Arm Description
Bupivacaine HCl surgical-site incision infiltration following spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Bupivacaine liposome injectable suspension
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl
Other Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine HCl surgical-site incision infiltration
Primary Outcome Measure Information:
Title
Amount of total opioid MME (milligram morphine equivalents) consumed at 24, 48 and 72hrs post-op
Description
3.1 To compare total opioid consumption through 72-hours following EXPAREL® + bupivacaine HCl surgical-site infiltration versus bupivacaine HCl alone at elective primary or repeat cesarean delivery after spinal anesthesia. 3.2 Primary outcome of this study is total opioid consumption measured in milligram morphine equivalents (MME) at 24-, 48- and 72-hours postoperatively and total MME for duration of hospital admission.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
time to initial rescue analgesia administration
Description
Time in hours and minutes
Time Frame
24 hours
Title
Numeric Pain Rating Score at 72 hours Postoperative
Description
postoperative pain assessment with NRS (Numeric Pain Rating Score). NRS score is comprised of 4 pain questions with the patient rating each one on a scale of 0(no pain) to 10(worst pain imaginable). Lower scores are favorable.
Time Frame
72 hours
Title
Overall Benefit of Analgesia Score at 72 hours Postoperative
Description
postoperative pain assessment with OBAS (Overall Benefit of Analgesia Score). The OBAS is comprised of 7 questions each being scored by the patient from 0(minimal pain) to 4(maximum imaginable pain). Each question is then added up to total the overall benefit of analgesia score. Lower scores are favorable.
Time Frame
72 hours
Title
Length of hospital stay
Description
measured in days and hours
Time Frame
72 hours
Title
Initiation of breastfeeding
Description
yes/no and time to initiation as measured in days and hours
Time Frame
72 hours
Title
Postpartum depression scores
Description
PHQ-9 postpartum depression scores. Possible range is 0-27. Lower scores mean less depression.
Time Frame
72 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligibility based on gender female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females 18 years of age and older at screening Subjects at 37 completed weeks of gestation or greater undergoing elective primary or repeat cesarean delivery (CD) Pfannenstiel incision Regional spinal anesthesia ASA classification I, II, or III Able to give informed consent English- or Spanish-speaking Exclusion Criteria: ASA classification IV Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia). Potential drug interaction(s) with bupivacaine Severe renal or hepatic dysfunction manifest as serum creatinine level >2 mg/dL, blood urea nitrogen level >50 mg/dL , serum aspartate aminotransferase level >3 times the upper limit of normal, or serum alanine aminotransferase level >3 times the ULN. Any clinically significant maternal or fetal event or condition arising during surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course. In this situation, the subject would be ineligible to receive study drug and withdrawn from the study. Chronic pain disorder manifest as a concurrent, painful, physical condition that may require long-term, consistent use of opioids postoperatively for pain that is not strictly related to the surgery and may confound postsurgical assessments. History of, suspected, or known addiction or abuse of illicit drug(s) or prescription medication(s) within the past 2 years. Planned concurrent surgical procedure except for salpingo-oophorectomy or tubal ligation. Subject at increased risk for bleeding or coagulation disorder (defined as platelet count less than 80,000/mm3 or international normalized ratio[INR] greater than 1.5). Pregnancy body mass index >50 kg/m2 or otherwise not anatomically appropriate to undergo local incision infiltration. Conversion of spinal anesthesia to general anesthesia due to incomplete neuraxial block and unsatisfactory surgical anesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Boardman, MD
Phone
7043553153
Email
amy.boardman@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Deanna Hamm, BS
Phone
7043557261
Email
deanna.hamm@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Boardman, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deanna Hamm
Phone
704-355-7261
Email
deanna.hamm@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Amy Boardman, MD
Phone
7043553153
Email
amy.boardman@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Lynn Am Boardman, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared

Learn more about this trial

Liposomal Bupivacaine + Bupivacaine vs. Bupivacaine Alone on Opioid Use After Elective c/Section

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