Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section
Summary
This randomized controlled trial will compare two different approaches to patient recovery after cesarean section: the current standard of care versus an alternate management protocol. The goal of this study is to investigate whether an "alternate management" protocol after cesarean sections will yield the same results as alternate management in other surgical fields, including decreased narcotic consumption and quicker return of bowel function, without compromising patient morbidity or satisfaction. The investigators will assess postoperative narcotic consumption as the primary outcome. Secondary outcomes will be return of bowel function, length of hospital stay, pain control, patient satisfaction, post-operative complications, and overall morbidity and mortality. Hypothesis: Initiating the alternate management protocol for cesarean sections will decrease narcotic consumption and hasten return of bowel function, without compromising patient satisfaction, level of pain control, or post-operative morbidity.
Timeline
- Start
- 2017-10-04
- Primary completion
- 2018-06-20
- Completion
- 2018-06-20
Publications
- Background Nelson G, Kalogera E, Dowdy SC. Enhanced recovery pathways in gynecologic oncology. Gynecol Oncol. 2014 Dec;135(3):586-94. doi: 10.1016/j.ygyno.2014.10.006. Epub 2014 Oct 12.
- Background Moore A, Costello J, Wieczorek P, Shah V, Taddio A, Carvalho JC. Gabapentin improves postcesarean delivery pain management: a randomized, placebo-controlled trial. Anesth Analg. 2011 Jan;112(1):167-73. doi: 10.1213/ANE.0b013e3181fdf5ee. Epub 2010 Nov 16.
- Background Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
- Background Committee opinion no. 633: Alcohol abuse and other substance use disorders: ethical issues in obstetric and gynecologic practice. Obstet Gynecol. 2015 Jun;125(6):1529-1537. doi: 10.1097/01.AOG.0000466371.86393.9b.
- Background Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. doi: 10.1542/peds.2013-1985. Epub 2013 Aug 26.
- 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.
- Background Guttuso T Jr, Shaman M, Thornburg LL. Potential maternal symptomatic benefit of gabapentin and review of its safety in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:280-3. doi: 10.1016/j.ejogrb.2014.08.013. Epub 2014 Aug 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 975 mg | Intravenous |
| Subject | Gabapentin | Small molecule | 600 mg | Oral |
| Subject | Ibuprofen | Small molecule | 600 mg | Oral |
| Subject | Ondansetron | Other / unclassified | 8 mg | Intravenous |
| Comparator | Hydromorphone | Other / unclassified | — | — |
| Background | Ketorolac | Other / unclassified | 30 mg | Intravenous |
| Comparator | Oxycodone/acetaminophen | Unknown | — | — |