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

NCT ID: NCT03738904

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-26
• Study Completion Date: 2022-08-18

Brief Summary

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.

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.

Conditions

Anorectal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1 (multimodal ERAS)

Arm1 (Multimodal ERAS):

Preoperative:

oral gabapentin 600mg and oral acetaminophen 1,000mg

Postoperative pain control:

1. Gabapentin oral 300 mg TID (#42, refill #1)

2. Acetaminophen oral 1000mg TID (#42, refill #1)

3. Ketorolac oral 10 mg TID (#15, refill #0)

4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0)

Postoperative laxative regimen:

1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days

2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements

3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements

Group Type: EXPERIMENTAL

ERAS

Intervention Type: COMBINATION_PRODUCT

Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol

Arm 2 (control)

Postoperative pain control:

1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0)

2. 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:

1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days

2. 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

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: COMBINATION_PRODUCT

Oxcodone PO Ketorolac IV only (intraop)

Interventions

ERAS

Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol

Intervention Type: COMBINATION_PRODUCT

Standard of care

Oxcodone PO Ketorolac IV only (intraop)

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Karen Zaghiyan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Zaghiyan, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai

Los Angeles, California, United States

Countries

United States

References

Yao LY, Parrish AB, Fleshner PR, Zaghiyan KN. Implementation of a Multimodal Enhanced Recovery Protocol in Ambulatory Anorectal Surgery: A Randomized Trial. Dis Colon Rectum. 2024 Oct 1;67(10):1304-1312. doi: 10.1097/DCR.0000000000003435. Epub 2024 Jul 17.

Reference Type: DERIVED

PMID: 39016381 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00054080

Identifier Type: -

Identifier Source: org_study_id