The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

NCT04033562 | Terminated Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 1351850
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Conditions

Opioid-use Disorder; Opioid Use; Opioid Dependence; Opioid Abuse; Medication Assisted Treatment; Infusion Catheter, Wound; Lidopatch; Ambu ACTion; Pregnancy Related; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being "no pain at all" and 10 being "the worst pain imaginable"

  post-operative until 60 hours postpartum

Secondary Outcomes (3)

• Rescue opioid consumption

  post-operative until 60 hours postpartum

• Survey of nursing staff

  between 48-60 hours post-Cesarean delivery

• Patient survey

  between 48-60 hourrs post-Cesarean delivery

Study Arms (2)

Lidoderm patch

ACTIVE COMPARATOR

Participants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours.

Drug: Lidocaine patch

Infusion pump

ACTIVE COMPARATOR

Participants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively.

Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr

Interventions

Lidocaine patch DRUG

Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.

Lidoderm patch

Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr DEVICE

Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.

Infusion pump

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy
• undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
• Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)

You may not qualify if:

• Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
• Non-English speaking
• Allergy to bupivacaine, lidocaine, zinc, silver or menthol
• Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
• History of glucose-6-phosphate deficiency
• Use of anti-arrhythmic drugs such as tocainide or mexiletine

Sponsors & Collaborators

• WellSpan Health: lead
• Ambu A/S: collaborator
• York Opioid Collaborative, Pennsylvania: collaborator

Study Sites (1)

WellSpan Health York Hospital

York, Pennsylvania, 17403, United States

Location

Related Publications (15)

• Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94. doi: 10.1016/j.ijoa.2006.02.003.

  PMID: 16798442 BACKGROUND

• Fredman B, Shapiro A, Zohar E, Feldman E, Shorer S, Rawal N, Jedeikin R. The analgesic efficacy of patient-controlled ropivacaine instillation after Cesarean delivery. Anesth Analg. 2000 Dec;91(6):1436-40. doi: 10.1097/00000539-200012000-00025.

  PMID: 11093995 BACKGROUND

• Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002 Jun;186(6):1188-91. doi: 10.1067/mob.2002.122984.

  PMID: 12066096 BACKGROUND

• Kainu JP, Sarvela J, Halonen P, Puro H, Toivonen HJ, Halmesmaki E, Korttila KT. Continuous wound infusion with ropivacaine fails to provide adequate analgesia after caesarean section. Int J Obstet Anesth. 2012 Apr;21(2):119-24. doi: 10.1016/j.ijoa.2011.12.009. Epub 2012 Feb 16.

  PMID: 22341892 BACKGROUND

• Lalmand M, Wilwerth M, Fils JF, Van der Linden P. Continuous Ropivacaine Subfascial Wound Infusion Compared With Intrathecal Morphine for Postcesarean Analgesia: A Prospective, Randomized Controlled, Double-Blind Study. Anesth Analg. 2017 Sep;125(3):907-912. doi: 10.1213/ANE.0000000000001892.

  PMID: 28368941 BACKGROUND

• Jolly C, Jathieres F, Keita H, Jaouen E, Guyot B, Torre A. Cesarean analgesia using levobupivacaine continuous wound infiltration: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:125-30. doi: 10.1016/j.ejogrb.2015.08.023. Epub 2015 Aug 25.

  PMID: 26366789 BACKGROUND

• Guidelines for laparoscopic surgery during pregnancy. Society of American Gastrointestinal Endoscopic Surgeons (SAGES). Surg Endosc. 1998 Feb;12(2):189-90. No abstract available.

  PMID: 9479743 BACKGROUND

• Habib AS, Polascik TJ, Weizer AZ, White WD, Moul JW, ElGasim MA, Gan TJ. Lidocaine patch for postoperative analgesia after radical retropubic prostatectomy. Anesth Analg. 2009 Jun;108(6):1950-3. doi: 10.1213/ane.0b013e3181a21185.

  PMID: 19448228 BACKGROUND

• Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3.

  PMID: 22861076 BACKGROUND

• Khanna M, Peters C, Singh JR. Treating pain with the lidocaine patch 5% after total knee arthroplasty. PM R. 2012 Sep;4(9):642-6. doi: 10.1016/j.pmrj.2012.06.003. Epub 2012 Jul 28.

  PMID: 22841969 BACKGROUND

• Bajwa SJ, Kaur J. Clinical profile of levobupivacaine in regional anesthesia: A systematic review. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):530-9. doi: 10.4103/0970-9185.119172.

  PMID: 24249993 BACKGROUND

• Brower MC, Johnson ME. Adverse effects of local anesthetic infiltration on wound healing. Reg Anesth Pain Med. 2003 May-Jun;28(3):233-40. doi: 10.1053/rapm.2003.50050. No abstract available.

  PMID: 12772142 BACKGROUND

• Tam KW, Chen SY, Huang TW, Lin CC, Su CM, Li CL, Ho YS, Wang WY, Wu CH. Effect of wound infiltration with ropivacaine or bupivacaine analgesia in breast cancer surgery: A meta-analysis of randomized controlled trials. Int J Surg. 2015 Oct;22:79-85. doi: 10.1016/j.ijsu.2015.07.715. Epub 2015 Aug 12.

  PMID: 26277531 BACKGROUND

• Scott NB. Wound infiltration for surgery. Anaesthesia. 2010 Apr;65 Suppl 1:67-75. doi: 10.1111/j.1365-2044.2010.06241.x.

  PMID: 20377548 BACKGROUND

• Cobb B, Liu R, Valentine E, Onuoha O. Breastfeeding after Anesthesia: A Review for Anesthesia Providers Regarding the Transfer of Medications into Breast Milk. Transl Perioper Pain Med. 2015;1(2):1-7.

  PMID: 26413558 BACKGROUND

Related Links

• Bupivacaine hydrochloride
• Wide-ranging online data for epidemiologic research (WONDER)

MeSH Terms

Conditions

Opioid-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Paul Burcher, MD

  WellSpan Health Ob-Gyn Residency Program Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 26, 2019
• Study Start: January 15, 2020
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

US (1)