Pain, PostoperativePhase 4SOOOTHENCT04680221
Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial
A Phase 4 study testing Liposomal bupivacaine, TAP block and Deposition of saline in people with Pain, Postoperative and Opioid Use, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Opioid Use
- What is being tested?
- Liposomal bupivacaine, TAP block and Deposition of saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unlabored, scheduled primary or repeat cesarean delivery
- Cesarean performed by obstetrician or surgically-trained family medicine physician
- Ability to complete numeric pain scale assessment and surveys
- Patients who do not speak English but are able to converse via an interpreter both in person and by phone
Who cannot join
- Complications requiring return to the operating room
- Unscheduled deliveries
- <18 years old, >45 years old
- Twin deliveries
- Preterm deliveries (<37 wks)
- Current or previous history of opioid-substance use disorder according to patient report or medical chart
Show all 15Show fewer
- Prescription of opioid medication filled in previous 30 days prior to delivery according to patient report, documentation in electronic medical record, or documentation in the prescription drug monitoring program
- Allergy to local anesthetics or NSAIDs
- Cardiovascular disease, eg arrhythmia, or ASA (American Society of Anesthesiologists) Class III or higher
- Diagnosis of liver disorder or dysfunction including fatty liver of pregnancy, preeclampsia with severe features including liver or kidney involvement
- Known significant renal disease, oliguria, or Cr >1.1.
- Platelet count less than or equal to 90k or rapid decline in third trimester or other coagulopathy
- Infection overlying the regional anesthesia site
- Hypovolemia prohibiting regional anesthesia
- General anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Truman Medical Center - Lakewood
Kansas City, Missouri, 64139
About this study
As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.
Read the detailed description
Nearly 1 in 3 women in the US deliver by cesarean delivery. After cesarean delivery, approximately 75-87% percent of women are discharged from the hospital with an opioid prescription. Most women fill that prescription and 1% continue to use those opioids 90 days after delivery despite no longer requiring them for pain control, predisposing them to opioid dependence. This study aims to determine if transverse abdominis plane (TAP) block using bupivacaine liposome suspension injection (EXPAREL®) significantly reduces the use of opioid medications after discharge in women undergoing scheduled cesarean delivery. The study is a proposed double-blinded, randomized controlled trial. Pregnant women who have completed 37 weeks gestation and are scheduled for cesarean delivery will be randomized to receive a TAP block with 80 ml of mixed liposomal bupivacaine or saline. Based on its use in other surgical settings, the investigators hypothesize that women who receive a liposomal bupivacaine TAP block will use significantly less opioids by postoperative day 7 as calculated in morphine milligram equivalents. In addition to overall consumption of opioids after discharge, other aims to be studied include inpatient opioid use, effect on pain scores, rates of postpartum depression, patient-perceived quality of breastfeeding, patient quality of recovery, and composite adverse outcomes.
With better overall pain control and less dependence on opioids postpartum, liposomal bupivacaine TAP blocks at the time of scheduled cesarean delivery may offer a highly effective analgesic alternative that can help shift the tide in the ongoing opioid epidemic among reproductive females.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- Liposomal bupivacaine, TAP block, Deposition of saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called EXPAREL
Deposition of liposomal bupivacaine
TAP blockProcedure or surgery
Transversus abdominis plane block performed to deposit anesthetic
Deposition of salineDrug
Deposition of saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | The transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right. Receives: Drug: Liposomal bupivacaine; Procedure: TAP block |
| Control | Placebo comparator | The transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side). Receives: Procedure: TAP block; Drug: Deposition of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Milligram Equivalents
Amount of opioid medications taken converted to Morphine Milligram Equivalents
Measured: 7 days after cesarean
Secondary outcomes (19)
Morphine Milligram Equivalents at 48 hours
Total opioid use inpatient at 48 hours as measured in Morphine Milligram Equivalents
Measured: Time surgery is complete to 48 hours
Numeric Rating Scale Pain Score on postoperative day 1
Highest documented pain score postoperative day #1 by Numeric Rating Scale Pain level [0-10]. Higher scores denote more pain.
Measured: Midnight to midnight postoperative day #1
Time to as needed opioid use
Time to first "as needed" opioid use while inpatient
Measured: Inpatient stay up to 6 days
Opioid-spared Percentage
Percentage of patients in each arm that did not receive any additional opioid after surgery
Measured: Inpatient stay up to 6 days
Edinburgh Postpartum Depression Scale Score at Discharge
Score on the Edinburgh Postpartum Depression scale [0-30] at discharge. Higher scores denote worse depression. A positive question 10 is also positive.
Measured: Inpatient stay up to 6 days
Edinburgh Postpartum Depression Scale Score at 7 days
Score on the Edinburgh Postpartum Depression scale [0-30] by phone interview postoperative day #7. Higher scores denote worse depression. A positive question 10 is also positive.
Measured: Postoperative day #7
Edinburgh Postpartum Depression Scale Score at 14 days
Score on the Edinburgh Postpartum Depression scale [0-30] at appointment postoperative day #14. Higher scores denote worse depression. A positive question 10 is also positive.
Measured: Postoperative day #14
Edinburgh Postpartum Depression Scale Score at 6 wks
Score on the Edinburgh Postpartum Depression scale [0-30] at 6 week postoperative appointment. Higher scores denote worse depression. A positive question 10 is also positive.
Measured: 6 weeks postpartum visit
Numeric Rating Scale Pain Score Postoperative day #7
Numeric Rating Scale Pain level [0-10] assessed by phone interview on Postoperative day #7. Higher scores denote more pain.
Measured: Postoperative day #7
Numeric Rating Scale Pain Score at Postoperative day #14
Numeric Rating Scale Pain level [0-10] at 2 week post op visit. Higher scores denote more pain.
Measured: Postoperative day #14
Numeric Rating Scale Pain Score at 6 wks
Numeric Rating Scale Pain level [0-10] at 6 week post op visit. Higher scores denote more pain.
Measured: Postpartum visit 6 wks
Quality of Recovery-15 at discharge
Quality of Recovery scale at discharge
Measured: Inpatient stay up to 6 days
Quality of Recovery-15 at 7 day
Quality of Recovery scale at Postoperative day #7 by phone interview [0-150].The Quality of Recovery-15 scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively.
Measured: Postoperative day #7
Quality of Recovery-15 at Postoperative day #14
Quality of Recovery scale at post op visit [0-150]. The Quality of Recovery-15 scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively.
Measured: Postoperative day #14
Quality of Recovery-15 at 6 weeks
Quality of Recovery scale at postpartum visit [0-150].The Quality of Recovery-15 scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively.
Measured: Postpartum visit 6 weeks
Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7
Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7 by phone interview [14-70] with higher scores denoting higher confidence
Measured: Postoperative day #7
Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #14
Breastfeeding Self-Efficacy Scale Short Form at post op visit [14-70] with higher scores denoting higher confidence
Measured: Postoperative day #14
Breastfeeding Self-Efficacy Scale Short Form at 6 weeks
Breastfeeding Self-Efficacy Scale Short Form at postpartum visit [14-70] with higher scores denoting higher confidence
Measured: Postpartum 6 weeks
Adverse Events
Adverse outcomes or side effects
Measured: Study duration ~ 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Mar 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Truman Medical Center
- Responsible party
- Principal investigator, Traci N Johnson, University of Missouri, Kansas City
- Investigators
- Devika Maulik, MD, Study chair, Children's Mercy Hospital Kansas CityGary Sutkin, MD, Study chair, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680221
- Sponsor's protocol ID
- 2026221
- Other IDs
- 21-018
- Acronym
- SOOOTHE
- Status last verified
- Mar 2025
- First submitted
- 29 Oct 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.
PubMed 32501202Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
PubMed 31348508Badreldin N, Grobman WA, Chang KT, Yee LM. Opioid prescribing patterns among postpartum women. Am J Obstet Gynecol. 2018 Jul;219(1):103.e1-103.e8. doi: 10.1016/j.ajog.2018.04.003. Epub 2018 Apr 7.
PubMed 29630887Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
PubMed 26996986Tuthill EL, McGrath JM, Graber M, Cusson RM, Young SL. Breastfeeding Self-efficacy: A Critical Review of Available Instruments. J Hum Lact. 2016 Feb;32(1):35-45. doi: 10.1177/0890334415599533. Epub 2015 Aug 28.
PubMed 26319113Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
PubMed 14649593Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PubMed 18818022Babazade R, Vadhera RB, Krishnamurthy P, Varma A, Doulatram G, Saade GR, Turan A. Acute postcesarean pain is associated with in-hospital exclusive breastfeeding, length of stay and post-partum depression. J Clin Anesth. 2020 Jun;62:109697. doi: 10.1016/j.jclinane.2019.109697. Epub 2019 Dec 31.
PubMed 31899076Mustafa HJ, Wong HL, Al-Kofahi M, Schaefer M, Karanam A, Todd MM. Bupivacaine Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine Administered After Cesarean Birth. Obstet Gynecol. 2020 Jul;136(1):70-76. doi: 10.1097/AOG.0000000000003886.
PubMed 32541292Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
PubMed 18020088
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial
- ClinicalTrials.gov ID
- NCT04680221
- Acronym / sponsor ID
- SOOOTHE / 2026221
- Conditions
- Pain, Postoperative, Opioid Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- Truman Medical Center
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 22 Dec 2020 (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.
As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.
Detailed description
Nearly 1 in 3 women in the US deliver by cesarean delivery. After cesarean delivery, approximately 75-87% percent of women are discharged from the hospital with an opioid prescription. Most women fill that prescription and 1% continue to use those opioids 90 days after delivery despite no longer requiring them for pain control, predisposing them to opioid dependence. This study aims to determine if transverse abdominis plane (TAP) block using bupivacaine liposome suspension injection (EXPAREL®) significantly reduces the use of opioid medications after discharge in women undergoing scheduled cesarean delivery. The study is a proposed double-blinded, randomized controlled trial. Pregnant women who have completed 37 weeks gestation and are scheduled for cesarean delivery will be randomized to receive a TAP block with 80 ml of mixed liposomal bupivacaine or saline. Based on its use in other surgical settings, the investigators hypothesize that women who receive a liposomal bupivacaine TAP block will use significantly less opioids by postoperative day 7 as calculated in morphine milligram equivalents. In addition to overall consumption of opioids after discharge, other aims to be studied include inpatient opioid use, effect on pain scores, rates of postpartum depression, patient-perceived quality of breastfeeding, patient quality of recovery, and composite adverse outcomes.
With better overall pain control and less dependence on opioids postpartum, liposomal bupivacaine TAP blocks at the time of scheduled cesarean delivery may offer a highly effective analgesic alternative that can help shift the tide in the ongoing opioid epidemic among reproductive females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Liposomal bupivacaine, Procedure: TAP blockThe transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right. |
| Control | Placebo comparator | Procedure: TAP block, Drug: Deposition of salineThe transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unlabored, scheduled primary or repeat cesarean delivery
- Cesarean performed by obstetrician or surgically-trained family medicine physician
- Ability to complete numeric pain scale assessment and surveys
- Patients who do not speak English but are able to converse via an interpreter both in person and by phone
Key exclusion criteria (15 listed)
- Complications requiring return to the operating room
- Unscheduled deliveries
- <18 years old, >45 years old
- Twin deliveries
- Preterm deliveries (<37 wks)
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 |
|---|---|---|
| Liposomal bupivacaineAlso: EXPARELDeposition of liposomal bupivacaine | Drug | Treatment |
| TAP blockTransversus abdominis plane block performed to deposit anesthetic | Procedure or surgery | Control, Treatment |
| Deposition of salineDeposition of saline | Drug | Control |
Primary outcome
Morphine Milligram Equivalents
Time frame: 7 days after cesarean
Amount of opioid medications taken converted to Morphine Milligram Equivalents
19 secondary outcomes
Morphine Milligram Equivalents at 48 hours
Time frame: Time surgery is complete to 48 hours
Numeric Rating Scale Pain Score on postoperative day 1
Time frame: Midnight to midnight postoperative day #1
Time to as needed opioid use
Time frame: Inpatient stay up to 6 days
Opioid-spared Percentage
Time frame: Inpatient stay up to 6 days
Edinburgh Postpartum Depression Scale Score at Discharge
Time frame: Inpatient stay up to 6 days
Edinburgh Postpartum Depression Scale Score at 7 days
Time frame: Postoperative day #7
Edinburgh Postpartum Depression Scale Score at 14 days
Time frame: Postoperative day #14
Edinburgh Postpartum Depression Scale Score at 6 wks
Time frame: 6 weeks postpartum visit
Numeric Rating Scale Pain Score Postoperative day #7
Time frame: Postoperative day #7
Numeric Rating Scale Pain Score at Postoperative day #14
Time frame: Postoperative day #14
Numeric Rating Scale Pain Score at 6 wks
Time frame: Postpartum visit 6 wks
Quality of Recovery-15 at discharge
Time frame: Inpatient stay up to 6 days
Quality of Recovery-15 at 7 day
Time frame: Postoperative day #7
Quality of Recovery-15 at Postoperative day #14
Time frame: Postoperative day #14
Quality of Recovery-15 at 6 weeks
Time frame: Postpartum visit 6 weeks
Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7
Time frame: Postoperative day #7
Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #14
Time frame: Postoperative day #14
Breastfeeding Self-Efficacy Scale Short Form at 6 weeks
Time frame: Postpartum 6 weeks
Adverse Events
Time frame: Study duration ~ 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 32501202Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.
- Background: PubMed 31348508Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
- Background: PubMed 29630887Badreldin N, Grobman WA, Chang KT, Yee LM. Opioid prescribing patterns among postpartum women. Am J Obstet Gynecol. 2018 Jul;219(1):103.e1-103.e8. doi: 10.1016/j.ajog.2018.04.003. Epub 2018 Apr 7.
- Background: PubMed 26996986Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
- Background: PubMed 26319113Tuthill EL, McGrath JM, Graber M, Cusson RM, Young SL. Breastfeeding Self-efficacy: A Critical Review of Available Instruments. J Hum Lact. 2016 Feb;32(1):35-45. doi: 10.1177/0890334415599533. Epub 2015 Aug 28.
- Background: PubMed 14649593Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
- Background: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Background: PubMed 18818022Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
- Background: PubMed 31899076Babazade R, Vadhera RB, Krishnamurthy P, Varma A, Doulatram G, Saade GR, Turan A. Acute postcesarean pain is associated with in-hospital exclusive breastfeeding, length of stay and post-partum depression. J Clin Anesth. 2020 Jun;62:109697. doi: 10.1016/j.jclinane.2019.109697. Epub 2019 Dec 31.
- Background: PubMed 32541292Mustafa HJ, Wong HL, Al-Kofahi M, Schaefer M, Karanam A, Todd MM. Bupivacaine Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine Administered After Cesarean Birth. Obstet Gynecol. 2020 Jul;136(1):70-76. doi: 10.1097/AOG.0000000000003886.
- Background: PubMed 18020088Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
- 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.
Devika Maulik, MD study chair
Children's Mercy Hospital Kansas City
Gary Sutkin, MD study chair
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine, TAP block and Deposition of saline in people with Pain, Postoperative and Opioid Use, run by University of Missouri, Kansas City at 1 site in United States.
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 15 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Morphine Milligram Equivalents (time frame: 7 days after cesarean). 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 NCT04680221, which also lists 11 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 25 Mar 2025.