Post-operative PainNCT05393908
Intraoperative TAP Block After Repeat Cesarean
A study testing TAP Block Group in people with Post-operative Pain, run by University of Massachusetts, Worcester.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- TAP Block Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery
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.
Read the 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.
- Conditions
- Post-operative Pain
- Being tested
- TAP Block Group
- Keywords
- Cesarean delivery, post-operative pain, TAP block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block GroupProcedure or surgery
Participants will receive a surgeon administered TAP block.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Group | Active comparator | Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery. Receives: Procedure: TAP Block Group |
| Standard of Care Postoperative Pain Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Narcotic Use in Morphine Equivalents
Daily Narcotic Use in Morphine Equivalents
Measured: From time of surgery through postpartum day 4
Secondary outcomes (5)
Time to first administered narcotic (oral or parental)
Time to first administered narcotic (oral or parental) post cesarean delivery
Measured: From time of surgery through postpartum day 4
Daily Average Pain Score
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Measured: From time of surgery through postpartum day 4
Daily Maximum Pain Score
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Measured: From time of surgery through postpartum day 4
Time to First Ambulation
Time to First Ambulation post cesarean delivery
Measured: From time of surgery through postpartum day 4
Time to First Solid Food
Time to First Solid Food
Measured: From time of surgery through postpartum day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: No funding became available for this study to be feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianna Wilkie, University of Massachusetts, Worcester
- Investigators
- Gianna Wilkie, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393908
- Sponsor's protocol ID
- STUDY00000407
- Status last verified
- Nov 2024
- First submitted
- 18 May 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30240657Tsai 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.
PubMed 29226150Kupiec 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.
PubMed 30215460Abdallah 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.
PubMed 22907337Kwikiriza 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.
PubMed 30383289Mishriky 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.
PubMed 22622954
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05393908
- Acronym / sponsor ID
- STUDY00000407
- Conditions
- Post-operative Pain
- Keywords
- Cesarean delivery, post-operative pain, TAP block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding became available for this study to be feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block Group | Active comparator | Procedure: TAP Block GroupParticipants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery. |
| Standard of Care Postoperative Pain Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP Block GroupParticipants will receive a surgeon administered TAP block. | Procedure or surgery | TAP Block Group |
Primary outcome
Daily Narcotic Use in Morphine Equivalents
Time frame: From time of surgery through postpartum day 4
Daily Narcotic Use in Morphine Equivalents
5 secondary outcomes
Time to first administered narcotic (oral or parental)
Time frame: From time of surgery through postpartum day 4
Daily Average Pain Score
Time frame: From time of surgery through postpartum day 4
Daily Maximum Pain Score
Time frame: From time of surgery through postpartum day 4
Time to First Ambulation
Time frame: From time of surgery through postpartum day 4
Time to First Solid Food
Time frame: From time of surgery through postpartum day 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 30240657Wilson 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.
- Background: PubMed 29226150Tsai 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.
- Background: PubMed 30215460Kupiec 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.
- Background: PubMed 22907337Abdallah 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.
- Background: PubMed 30383289Kwikiriza 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.
- Background: PubMed 22622954Mishriky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianna Wilkie, MD principal investigator
University of Massachusetts, Worcester
Questions about this trial
What is this clinical trial studying?
A study testing TAP Block Group in people with Post-operative Pain, run by University of Massachusetts, Worcester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Narcotic Use in Morphine Equivalents (time frame: From time of surgery through postpartum day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393908, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.