Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
Condition: Anorectal Disorder
MeSH terms: Rectal Diseases
Intervention: ERAS; Standard of care
Intervention description: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol; Oxcodone PO Ketorolac IV only (intraop)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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