Intraoperative TAP Block After Repeat Cesarean
Primary Purpose
Post-operative Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TAP Block Group
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring Cesarean delivery, post-operative pain, TAP block
Eligibility Criteria
Inclusion Criteria:
- Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age.
- Pregnancy and delivery care obtained at UMass Memorial Medical Center
- Patients able to provide written informed consent
- English, Spanish, or Portuguese-speaking patients
Exclusion Criteria:
- Participants who are under the age of 18 years
- Active labor.
- Baseline pain score > 6.
- Unable to provide informed consent.
- Prisoners will be excluded from this research.
- Narcotic use in the 2 weeks prior to delivery.
- Active substance abuse.
- Inability to take narcotic analgesia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
TAP Block Group
Standard of Care Postoperative Pain Control
Arm Description
Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery.
Participants will not receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery and will receive the routine standard of care for post-operative pain control.
Outcomes
Primary Outcome Measures
Daily Narcotic Use in Morphine Equivalents
Daily Narcotic Use in Morphine Equivalents
Secondary Outcome Measures
Time to first administered narcotic (oral or parental)
Time to first administered narcotic (oral or parental) post cesarean delivery
Daily Average Pain Score
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Daily Maximum Pain Score
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Time to First Ambulation
Time to First Ambulation post cesarean delivery
Time to First Solid Food
Time to First Solid Food
Full Information
NCT ID
NCT05393908
First Posted
May 18, 2022
Last Updated
May 2, 2023
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT05393908
Brief Title
Intraoperative TAP Block After Repeat Cesarean
Official Title
Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.
Detailed Description
Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Cesarean delivery, post-operative pain, TAP block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAP Block Group
Arm Type
Active Comparator
Arm Description
Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery.
Arm Title
Standard of Care Postoperative Pain Control
Arm Type
No Intervention
Arm Description
Participants will not receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery and will receive the routine standard of care for post-operative pain control.
Intervention Type
Procedure
Intervention Name(s)
TAP Block Group
Intervention Description
Participants will receive a surgeon administered TAP block.
Primary Outcome Measure Information:
Title
Daily Narcotic Use in Morphine Equivalents
Description
Daily Narcotic Use in Morphine Equivalents
Time Frame
From time of surgery through postpartum day 4
Secondary Outcome Measure Information:
Title
Time to first administered narcotic (oral or parental)
Description
Time to first administered narcotic (oral or parental) post cesarean delivery
Time Frame
From time of surgery through postpartum day 4
Title
Daily Average Pain Score
Description
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Time Frame
From time of surgery through postpartum day 4
Title
Daily Maximum Pain Score
Description
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Time Frame
From time of surgery through postpartum day 4
Title
Time to First Ambulation
Description
Time to First Ambulation post cesarean delivery
Time Frame
From time of surgery through postpartum day 4
Title
Time to First Solid Food
Description
Time to First Solid Food
Time Frame
From time of surgery through postpartum day 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age.
Pregnancy and delivery care obtained at UMass Memorial Medical Center
Patients able to provide written informed consent
English, Spanish, or Portuguese-speaking patients
Exclusion Criteria:
Participants who are under the age of 18 years
Active labor.
Baseline pain score > 6.
Unable to provide informed consent.
Prisoners will be excluded from this research.
Narcotic use in the 2 weeks prior to delivery.
Active substance abuse.
Inability to take narcotic analgesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianna Wilkie, MD
Phone
508-334-9189
Email
Gianna.Wilkie@umassmemorial.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianna Wilkie, MD
Organizational Affiliation
University of Massachusetts Chan Medical School
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30240657
Citation
Wilson RD, Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G. Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1). Am J Obstet Gynecol. 2018 Dec;219(6):523.e1-523.e15. doi: 10.1016/j.ajog.2018.09.015. Epub 2018 Sep 18.
Results Reference
background
PubMed Identifier
29226150
Citation
Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.
Results Reference
background
PubMed Identifier
30215460
Citation
Kupiec A, Zwierzchowski J, Kowal-Janicka J, Gozdzik W, Fuchs T, Pomorski M, Zimmer M, Kubler A. The analgesic efficiency of transversus abdominis plane (TAP) block after caesarean delivery. Ginekol Pol. 2018;89(8):421-424. doi: 10.5603/GP.a2018.0072.
Results Reference
background
PubMed Identifier
22907337
Citation
Abdallah FW, Halpern SH, Margarido CB. Transversus abdominis plane block for postoperative analgesia after Caesarean delivery performed under spinal anaesthesia? A systematic review and meta-analysis. Br J Anaesth. 2012 Nov;109(5):679-87. doi: 10.1093/bja/aes279. Epub 2012 Aug 19.
Results Reference
background
PubMed Identifier
30383289
Citation
Kwikiriza A, Kiwanuka JK, Firth PG, Hoeft MA, Modest VE, Ttendo SS. The analgesic effects of intrathecal morphine in comparison with ultrasound-guided transversus abdominis plane block after caesarean section: a randomised controlled trial at a Ugandan regional referral hospital. Anaesthesia. 2019 Feb;74(2):167-173. doi: 10.1111/anae.14467. Epub 2018 Nov 1.
Results Reference
background
PubMed Identifier
22622954
Citation
Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24.
Results Reference
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Intraoperative TAP Block After Repeat Cesarean
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