Efficacy of Extended-Release Liposomal Bupivacaine for Post-Partum Pain Management Following Obstetrical Laceration

NCT03152877 | Completed

• 1 other identifier: 216440
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

We propose a prospective, randomized, single blinded trial with subjects recruited from the WRNMMC Labor and Delivery Unit to study post-partum efficacy of Exparel® for pain control in patients undergoing a vaginal delivery who sustained a second, third, or fourth degree obstetrical laceration. Subjects who meet inclusion criteria and agree to participate in the study will be consented upon admission for active labor or induction of labor and will be randomized to receive either 20mL of liposomal bupivacaine or 20ml of 0.25% plain bupivacaine, infiltrated through the perineum at completion of their obstetrical repair. Current standard of care is to receive no injection of local anesthetic upon completion of the repair. The primary aim of the trial will be to evaluate post-partum pain using a visual analogue pain scale at days 1, 3 and 7 postpartum. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual post-partum pain control regimen. We anticipate a 30% difference in post-operative pain measurements between the Exparel® group and the plain bupivacaine group. Other aims of this study are to evaluate total medication usage, comparing the study group to the control, and compare quality of life measures between the two study groups.

Conditions

Pain, Obstetric

Outcome Measures

Primary Outcomes (1)

• Change in postpartum pain control following repair of a second, third, or fourth degree obstetric laceration

  The primary goal of the study is to assess how effective the study medication is in providing adequate pain control following repair of a second, third, or fourth degree laceration; therefore, the subjects' post-partum pain will be assessed at various intervals following the repair. On post-partum day one, subjects will be asked questions regarding their pain level in the vaginal area according to the Defense and Veterans Pain Rating Scale, which is an 11-point visual analog pain scale.

  Pain control will be assessed at 1, 3, and 7 days after delivery

Secondary Outcomes (2)

• Effect on pain medication consumption

  Pain medication consumption will be assessed at 1, 3, and 7 days after delivery

• Impact pain has on quality of life

  Quality of life will be assessed at 1, 3, abd 7 days after delivery

Study Arms (2)

Liposomal bupivacaine treatment group

EXPERIMENTAL

20cc of liposomal bupivacaine will be injected into the vaginal/perineal laceration site, in subjects in the experimental arm, following completion of the surgical repair.

Drug: Bupivacaine Liposome Injectable Product

0.25% plain bupivacaine treatment group

ACTIVE COMPARATOR

20cc of 0.25% plain bupivacaine will be injected into the vaginal/perineal laceration site, in subjects in the active comparator arm, following completion of the surgical repair.

Drug: 0.25% plain bupivacaine

Interventions

Bupivacaine Liposome Injectable Product DRUG

20cc of liposomal bupivacaine will be injected into the vaginal/perineal laceration site, once, following completion of the surgical repair.

Also known as: Exparel

Liposomal bupivacaine treatment group

0.25% plain bupivacaine DRUG

20cc of 0.25% plain bupivacaine will be injected into the vaginal/perineal laceration site, once, following completion of the surgical repair.

0.25% plain bupivacaine treatment group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant females \>18 years of age who sustained a second, third, or fourth degree laceration during a vaginal delivery, or operative vaginal delivery (forceps-assisted or vacuum-assisted) at Walter Reed National Military Medical Center

You may not qualify if:

• Known allergy to amide local anesthetics
• Unstable cardiac arrhythmia
• Hepatic impairment
• Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery
• Significant history of opioid or alcohol abuse or addiction (requiring treatment)
• Delivery of a fetal demise

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Related Publications (14)

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 BACKGROUND

• 2. The Joint Commission. Facts about pain management. Available from: http://www.jointcommission.org/pain_management/. Accessed February 1, 2014.

  BACKGROUND

• 3. Food and Drug Administration. FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure. Available from: http://www.fda.gov/drugs/drugsafety/ucm239821.htm. Accessed February 1, 2014.

  BACKGROUND

• Lyu H, Wick EC, Housman M, Freischlag JA, Makary MA. Patient satisfaction as a possible indicator of quality surgical care. JAMA Surg. 2013 Apr;148(4):362-7. doi: 10.1001/2013.jamasurg.270.

  PMID: 23715968 BACKGROUND

• Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.

  PMID: 14622770 BACKGROUND

• Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

  PMID: 22285545 BACKGROUND

• Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

  PMID: 22900785 BACKGROUND

• Marcet JE, Nfonsam VN, Larach S. An extended paIn relief trial utilizing the infiltration of a long-acting Multivesicular liPosome foRmulation Of bupiVacaine, EXPAREL (IMPROVE): a Phase IV health economic trial in adult patients undergoing ileostomy reversal. J Pain Res. 2013 Jul 18;6:549-55. doi: 10.2147/JPR.S46467. Print 2013.

  PMID: 23901290 BACKGROUND

• Vogel JD. Liposome bupivacaine (EXPAREL(R)) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial. J Pain Res. 2013 Jul 29;6:605-10. doi: 10.2147/JPR.S46950. Print 2013.

  PMID: 23935387 BACKGROUND

• Hu D, Onel E, Singla N, Kramer WG, Hadzic A. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig. 2013 Feb;33(2):109-15. doi: 10.1007/s40261-012-0043-z.

  PMID: 23229686 BACKGROUND

• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.

  PMID: 22067185 BACKGROUND

• Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.

  PMID: 22570563 BACKGROUND

• Chang ZM, Heaman MI. Epidural analgesia during labor and delivery: effects on the initiation and continuation of effective breastfeeding. J Hum Lact. 2005 Aug;21(3):305-14; quiz 315-9, 326. doi: 10.1177/0890334405277604.

  PMID: 16113019 BACKGROUND

• Baxter R, Bramlett K, Onel E, Daniels S. Impact of local administration of liposome bupivacaine for postsurgical analgesia on wound healing: a review of data from ten prospective, controlled clinical studies. Clin Ther. 2013 Mar;35(3):312-320.e5. doi: 10.1016/j.clinthera.2013.02.005. Epub 2013 Mar 1.

  PMID: 23453403 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher J Strauchon, DO

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FPMRS Fellow, WRNMMC

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 15, 2017
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)