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limited enrollment and unable to enroll subjects to reach statistical significance
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| Name | Class |
|---|---|
| Ambu A/S | INDUSTRY |
| York Opioid Collaborative, Pennsylvania | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch | Drug | Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue opioid consumption | Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively | post-operative until 60 hours postpartum |
| Survey of nursing staff |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Burcher, MD | WellSpan Health Ob-Gyn Residency Program Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WellSpan Health York Hospital | York | Pennsylvania | 17403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16798442 | Background | 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. | |
| 11093995 | Background |
| Label | URL |
|---|---|
| Bupivacaine hydrochloride | View source |
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| 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. |
|
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 |
| 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 |
| 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. |
| 12066096 | 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. |
| 22341892 | 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. |
| 28368941 | 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. |
| 26366789 | 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. |
| 9479743 | 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. |
| 19448228 | 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. |
| 22861076 | 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. |
| 22841969 | 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. |
| 24249993 | 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. |
| 12772142 | 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. |
| 26277531 | 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. |
| 20377548 | Background | Scott NB. Wound infiltration for surgery. Anaesthesia. 2010 Apr;65 Suppl 1:67-75. doi: 10.1111/j.1365-2044.2010.06241.x. |
| 26413558 | 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. |
| Wide-ranging online data for epidemiologic research (WONDER) | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 16, 2023 | Jul 7, 2023 | 6 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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