Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery

The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal surgery versus the standard of care for managing pain. This use of a more aggressive pain regimen is considered an enhanced recovery after surgery (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by both decreasing the use of narcotics and their detrimental effects as well as increasing the benefit of using additional non-narcotic pain medication.

Study Overview

• Status: Completed
• Conditions: Anorectal Disorder
• Intervention / Treatment: Combination product: ERAS; Combination product: Standard of care

Detailed Description

Although pain is a predictable part of the postoperative experience, inadequate management of pain is common and can have profound implications Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. Mostly, pain is treated with opioids which are narcotics. medically they are primarily used for pain relief and these are historically considered "safe" drugs as they do not impose an increased risk of bleeding, kidney, or stomach problems. However, many patients taking high dose opioids have a higher risk of constipation. Unrelieved postoperative pain may result in economic and medical implications such as extended lengths of stay, readmissions, and patient dissatisfaction with medical care. With the rising concern over narcotic use, physicians are increasingly seeking alternative ways to help patients manage pain throughout their hospital stay and beyond However, few studies in anorectal surgery have shown that using an aggressive postoperative non-narcotic pain regimen (ERAS) can help reduce postoperative pain and decreased returns to emergency care.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
• Males or females, age 18 to 70 years old at the time of study screening;
• American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective anorectal surgery
• Patients undergoing the following hemorrhoid surgeries will be included:
• Excisional single column or multiple column hemorrhoidectomy including internal and external component
• Stapled hemorrhoidpexy (aka procedure for prolapsed hemorrhoids with or without excision of external hemorrhoid or skin tag)
• Trans anal hemorrhoidal dearterialization with mucopexy (THD) with or without excision of external hemorrhoid or skin tag
• Patients undergoing the following anal fistula surgery will be included:
• Anal fistulotomy or fistulectomy of intersphincteric or tran-sphincteric fistula with wound > 1 cm
• Endorectal or an cutaneous advancement flap for anal fistula re-pair

Exclusion Criteria:

• Unable or unwilling to provide informed consent or comply with study procedures
• American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries
• Children <18
• Patients over age 70 due to small risk of altered mental status with gabapentin in elderly6
• Patients with impaired renal clearance (baseline creatinine 1.5mg/dL, creatinine clearance < 60ml/min or known renal dysfunction)
• Patients with known liver dysfunction (Childs class A, B, or C)
• Patients with prior liver or kidney transplant
• Pregnant patients
• Patients requiring emergency surgery
• Patients taking narcotics or steroids at the time of surgery
• Patients having external hemorrhoidectomy or skin anal tag excision only
• Patients having anal abscess drainage, seton placement without definitive fistula repair, or ligation of intersphincteric fistula tract, subcutaneous fistulotomy or fistulotomy with wound <1 cm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (multimodal ERAS); Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: Gabapentin oral 300 mg TID (#42, refill #1); Acetaminophen oral 1000mg TID (#42, refill #1); Ketorolac oral 10 mg TID (#15, refill #0); Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: Daily MiraLAX 1 scoop in 1 glass of water for 15 days; Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements; Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements	Combination product: ERAS; Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol
Active Comparator: Arm 2 (control); Postoperative pain control: Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0); Patients will be allowed to take oral acetaminophen and ibuprofen over the counter if needed but active narcotic-sparing pain management regimen will not be implemented Postoperative laxative regimen: Daily MiraLAX 1 scoop in 1 glass of water for 15 days; Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements Daily mineral oil 1 table spoon if no bowel movement by POD2 until regu-lar bowel movements	Combination product: Standard of care; Oxcodone PO Ketorolac IV only (intraop)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Narcotic Use Postoperatively in Oral Morphine Equivalents	Total amount of narcotics used	1 week postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Postoperative Pain Scores	Level of pain measured on a scale of 0-10 with 0 being the lowest level of pain and 10 being the highest level of pain as reported by the participant	1 week postoperatively
Complications	Number of participants who experienced complications	1 month postoperatively

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Karen Zaghiyan, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2018
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases
• Other Study ID Numbers: Pro00054080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No