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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04033562
• Other study ID #: 1351850
• Status: Terminated
• Phase: Phase 4
• Start date: January 15, 2020
• Est. completion date: May 17, 2021

Study information

• Verified date: June 2021
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 17, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

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

Device:
• Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr
Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.

Locations

Country	Name	City	State
United States	WellSpan Health York Hospital	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
WellSpan Health	Ambu A/S, York Opioid Collaborative, Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

Brower MC, Johnson ME. Adverse effects of local anesthetic infiltration on wound healing. Reg Anesth Pain Med. 2003 May-Jun;28(3):233-40. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Guidelines for laparoscopic surgery during pregnancy. Society of American Gastrointestinal Endoscopic Surgeons (SAGES). Surg Endosc. 1998 Feb;12(2):189-90. — View Citation

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. — View Citation

Jolly C, Jathières F, Keïta 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. — View Citation

Kainu JP, Sarvela J, Halonen P, Puro H, Toivonen HJ, Halmesmäki 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rescue opioid consumption	Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively	post-operative until 60 hours postpartum
Secondary	Survey of nursing staff	1-item questionnaire to assess whether nursing felt that patient benefited from therapy. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)	between 48-60 hours post-Cesarean delivery
Secondary	Patient survey	2-item questionnaire to assess whether patient felt like she benefited from therapy and whether she would elect to use it again in a future C-section. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)	between 48-60 hourrs post-Cesarean delivery

External Links

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