Actively Recruiting

Phase 4
Age: 18Years - 100Years
All Genders
ID04248205

Intra-operative Use of Ketamine for Post-Operative Analgesia in Patients Undergoing Hemorrhoidectomy: A Prospective, Randomized Controlled Trial

Led by University of Oklahoma · Updated on 2026-04-01

100

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of ketamine for pain relief after surgery in patients undergoing hemorrhoidectomy for Grade III or IV hemorrhoids. This prospective, randomized study compares intraoperative ketamine infusion with no ketamine in about 100 patients. Participants will not know which treatment they receive, but the doctors will, to examine the differences in post-operative pain and narcotic use. Participants are randomly assigned to one of two groups: one receives a ketamine dose of 0.3 mg/kg intravenously before surgery and an additional dose if the procedure lasts longer than one hour, along with standard general anesthesia and local nerve block. The other group receives standard anesthesia without ketamine. All participants receive pre-medications including Gabapentin, Ultram, and Tylenol, and will have surgery performed by one of three surgeons using the same ligasure hemorrhoidectomy method. During and after surgery, participants will track their pain using numeric and facial scales and will be contacted for pain assessments on several post-operative days. Follow-up occurs at two weeks post-surgery to count remaining narcotic pills and review recovery. Data collected include narcotic use and pain levels over 10 days. The study aims to analyze these outcomes after all participants complete follow-up, expected over 8 to 12 months.

CONDITIONS

Brief Title

Ketamine for Post-operative Analgesia in Hemorrhoidectomy

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 100 years
  • Undergoing hemorrhoidectomy surgery for Grade III or IV hemorrhoids
Not Eligible

You will not qualify if you...

  • Unable to undergo general anesthesia
  • Contraindications to hemorrhoidectomy surgery
  • History of schizophrenia or other hallucinatory psychiatric illnesses
  • History of psychosis
  • Chronic narcotic use defined as having a pain contract with a pain management specialist and no narcotic use for one month prior to surgery is excluded if not met

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants undergo hemorrhoidectomy surgery with general anesthesia. Those randomized to the ketamine group receive an intraoperative ketamine infusion for post-operative pain management, while the control group receives standard anesthesia without ketamine.

1 visit (in-person surgery and anesthesia administration)

Post-operative Follow-up

Duration - 2 weeks

Participants follow post-operative care instructions at home, including pain medication and self-monitoring of pain. They are contacted by the research team to assess pain levels and attend a post-operative clinic visit at 2 weeks for medication usage assessment and further pain evaluation.

1 clinic visit and multiple phone contacts for pain assessment

Trial Site Locations

Total: 1 location

1

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

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Research Team

S

Steven N Carter, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of low-dose ketamine on post-operative serum IL-6 production among elective surgical patients: a randomized clinical trial.

Tonny Stone Luggya, Tony Roche, Lameck Ssemogerere...

https://pubmed.ncbi.nlm.nih.gov/29062346