Ketamine for Post-operative Analgesia in Hemorrhoidectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04248205|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2020
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Drug: Ketamine||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Intra-operative Use of Ketamine for Post-Operative Analgesia in Patients Undergoing Hemorrhoidectomy: A Prospective, Randomized Controlled Trial.|
|Estimated Study Start Date :||April 3, 2020|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||July 28, 2022|
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.
Standard general anesthesia PLUS ketamine will be given for post-operative analgesia
No Intervention: Control group
This group will only receive the standard anesthesia during surgery with no ketamine.
- 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.
- 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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248205
|Contact: Steven N Carter, MD||405-271-8001 ext firstname.lastname@example.org|
|Contact: Theresa J Lander||405271-8001 ext email@example.com|
|United States, Oklahoma|
|OU Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Steven N Carter, MD||University of Oklahoma|