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WithdrawnNCT02847013Updated Jan 31, 2020

The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section

A Phase 2/3 interventional study of TAP block w Liposomal bupivacaine and TAP block w normal saline in Pain, sponsored by Milton S. Hershey Medical Center. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-31.

Sponsored by Milton S. Hershey Medical Center · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.

02

Conditions studied

  • Pain

Keywords

  • Postcesarean Section
  • Postoperative
03

In context

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients >18 years of age
  • Scheduled cesarean section with or without bilateral tubal ligation
  • Planned performance of a Pfannenstiel incision
  • Patients are schedule to have a cesarean section with a member of the Women's Health or Maternal and Fetal Medicine Departments at Penn State University Hershey S. Medical Center

Exclusion criteria

Exclusion Criteria:

  • History of opioid use
  • History of chronic pain syndrome
  • Use of general anesthesia during cesarean delivery
  • Postoperative SICU admission
  • Postpartum hemorrhage (defined as an Estimated Blood Loss of greater then 1,000mL upon completion of the cesarean section)
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo- Tap block w normal saline

    After completion of surgery with closer of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, 20cc of Normal saline will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm

    Procedure: TAP block w normal saline

  • Experimental
    Intervention-Tap block w Liposomal bupivacaine

    After completion of surgery w closure of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, Liposomal bupivacaine 0.33% (10 ml diluted to 20 ml using sterile normal saline) will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm

    Drug: TAP block w Liposomal bupivacaine

Interventions

  • DrugTAP block w Liposomal bupivacaine

    TAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs)

    Also known as: Exparel

  • ProcedureTAP block w normal saline

    TAP block w normal saline -preservative free 0.9% sodium chloride (20mLs)

06

What researchers measure

Primary outcomes

  1. Postoperative narcotic use

    Patient use of standard postoperative narcotics (percocet) will be measured.

    Time frame: initial 48 hours postoperatively

Secondary outcomes

  1. Subjective pain scores using 1-10 VAS system

    Subjective pain scores using 1-10 VAS system will be measured

    Time frame: initial 48 hours postoperatively

07

Study locations

1 site
  • Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02847013
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Jaimey M. Pauli, MD (OB/GYN Resident, Milton S. Hershey Medical Center) — Principal investigator
First posted
Jul 27, 2016
Primary completion
Dec 17, 2019
Last update
Jan 31, 2020

Study contacts

Jaimey Pauli, MD
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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