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

Anorectal Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738904
• Other study ID #: Pro00054080
• Status: Completed
• Phase: Phase 4
• Start date: October 26, 2018
• Est. completion date: August 18, 2022

Study information

• Verified date: November 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Disorder
• Rectal Diseases

Intervention

Combination Product:
• ERAS
Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol
• Standard of care
Oxcodone PO Ketorolac IV only (intraop)

Locations

Country	Name	City	State
United States	Cedars Sinai	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Narcotic Use Postoperatively in Oral Morphine Equivalents	Total amount of narcotics used	1 week postoperatively
Secondary	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
Secondary	Complications	Number of participants who experienced complications	1 month postoperatively