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Ketamine for Post-operative Analgesia in Hemorrhoidectomy

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ClinicalTrials.gov Identifier: NCT04248205
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE January 27, 2020
First Posted Date  ICMJE January 30, 2020
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
Change in post-operative narcotic usage [ Time Frame: two weeks post-operation ]
Standardized pain control regimen with ketamine; at two week surgical follow-up visit patient will bring their oxycodone prescription and we will count the number of pills that were taken.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
Decrease in post-operative narcotic usage [ Time Frame: two weeks post-operation ]
Standardized pain control regimen with ketamine; at two week surgical follow-up visit patient will bring their oxycodone prescription and we will count the number of pills that were taken.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
Change in post-op pain [ Time Frame: Post-op days 1, 3, 5, 7, and 10 ]
Wong-Baker FACES Pain Rating Scale, which ranges from 0 to 10, with 0 being represented by a happy face indicating "No Hurt" to 10, represented by a crying face, indicating "hurts like the worst pain imaginable".
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
Reduction of post-op pain [ Time Frame: Post-op days 1, 3, 5, 7, and 10 ]
Wong-Baker FACES pain scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Post-operative Analgesia in Hemorrhoidectomy
Official Title  ICMJE Intra-operative Use of Ketamine for Post-Operative Analgesia in Patients Undergoing Hemorrhoidectomy: A Prospective, Randomized Controlled Trial.
Brief Summary This is a prospective, randomized study of ketamine versus no ketamine in approximately 100 patients undergoing hemorrhoidectomy for Grade III or IV hemorrhoids. The participants will be blinded to which treatment arm they are assigned, because participants will be under anesthesia when the ketamine is administered. The investigators will know whether the participant receives ketamine or not.
Detailed Description

Participants will be randomized into 2 groups: intraoperative ketamine infusion during operation or routine anesthesia with no ketamine. Participants are pre-medicated in the operating room with the same regimen: Gabapentin 300mg, Ultram 50mg, and Tylenol 1000mg.

For participants in the ketamine group, a pain dose of ketamine 0.3mg/kg IV bolus dosing will be given prior to incision. If the procedure lasts longer than 1 hour, an additional bolus dose will be given. All participants will undergo general anesthesia and receive routine anesthesia care, aside from ketamine verus no ketamine. All participants will also receive standard local anesthesia including a local regional perianal nerve block.

The procedure will be performed by three different surgeons, with the surgery done the same way using ligasure hemorrhoidectomy. Participants will all be sent home with the same post-operative instructions and pain medications to include: Tylenol 1000mg, oxycodone 5mg, ibuprofen 800mg, fiber/miralax, and tub baths twice daily for 15 minutes.

A patient pain handout will be given to participants upon discharge with instructions to rate pain according to a numeric rating scale and the Wong-Baker FACES pain scale. Participants will be contacted by a member of the research team to assess their post-operative pain based on a numeric rating scale. All participants will undergo post-operative clinic follow-up at 2 weeks post-operation. At that time they will be instructed to bring their oxycodone bottle to assess how many pills the participant required. The clinic medical assistant will count the number of remaining pills and record this in the electronic medical record. If a participant forgets their pain scale record or medications, a post-operative phone interview will be performed after the clinic appointment to gather this information.

The investigators will randomize 50 participants to the ketamine group and 50 participants to the placebo group. Study will take place until all participants have been analyzed, approximately 8-12 months. Randomization will occur using a statistical method with study arms placed into individual envelopes that will be stored at the University of Oklahoma (OU) Surgery Center. The investigator will blindly pull an envelope from the stack which will identify the participant's treatment arm. The participants will be blinded and not informed of their arm of the study as to not create bias toward subjective pain. Practitioners will not be blinded for ease of medication administration. The procedures will occur at OU Surgery Center by one of three surgeons. Anesthesiologists will administer ketamine based on study arm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hemorrhoids
Intervention  ICMJE Drug: Ketamine
Standard general anesthesia PLUS ketamine will be given for post-operative analgesia
Study Arms  ICMJE
  • Active Comparator: Intraoperative ketamine infusion
    Subjects in this group will receive standard anesthesia during surgery and a dose of ketamine at 0.3 mg/kg IV bolus prior to surgical incision. If the procedure lasts more than 1 hour, an additional bolus dose will be given.
    Intervention: Drug: Ketamine
  • No Intervention: Control group
    This group will only receive the standard anesthesia during surgery with no ketamine.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 28, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults aged 18-100
  • Undergoing a hemorrhoidectomy for Grade III or IV hemorrhoids.

Exclusion Criteria:

  • Inability to undergo general anesthesia
  • Contraindications to hemorrhoidectomy
  • History of schizophrenia or other hallucinatory psychiatric illnesses
  • History of psychosis
  • Chronic narcotic usage defined as either having a pain contract with a pain management specialist and no narcotic usage for one month prior to hemorrhoidectomy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steven N Carter, MD 405-271-8001 ext 55000 steven-carter@ouhsc.edu
Contact: Theresa J Lander 405271-8001 ext 43230 theresa-lander@ouhsc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04248205
Other Study ID Numbers  ICMJE 11475
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven N Carter, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP