Pre-Emptive Analgesia in Ano-Rectal Surgery (PEAARS)
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|ClinicalTrials.gov Identifier: NCT02402543|
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : January 16, 2018
The perianal region is the region around the anus. Administering a pain medication before a surgery starts is called preemptive analgesia. In some studies, this technique has been shown to be an effective way to reduce the pain that a patient experiences in the post-operative timeframe to a greater extent than would be expected simply from the pain medications alone. One theory of why this occurs suggests that the preemptive analgesia desensitizes brain and nerves to pain, thereby decreasing the response to painful stimuli, like surgery when they occur. This leads to a decrease in the amount of narcotic pain medication required after the procedure, which leads to less side effects and a quicker return to normal functioning. As perianal surgeries do not usually include a long stay in the hospital, controlling post-procedure pain is a priority.
The use of preemptive analgesia is in other types of surgeries, such as orthopedics, is well established, but as the perianal region has not been well studied, its use is not the standard of care. This type of analgesia uses a combination of medications that are already in use for post-operative and non-operative pain control and administers them orally prior to the patient undergoing general anesthesia. The side effects of the medications are the same as if they had been given after surgery or for non-surgical pain.
The concept of preemptive analgesia is established in other types of surgeries and it has solid basic science to support its use. The purpose of this randomized, double-blind, placebo controlled study is to determine if patients undergoing perianal surgeries could benefit from preemptive pain control. The primary outcome will be whether patients experience less post-operative pain. Patient post-operative consumption and latency until use of narcotic pain medication will be the secondary outcomes. The investigators believe that the patients receiving pain medications before their operation will require less pain medication after surgery, with minimal increased risk to the patient.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids Fissure in Ano Rectal Fistula Anal Condyloma||Drug: Gabapentin Drug: Ketamine Drug: Acetaminophen Drug: Dexamethasone Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pre-Emptive Analgesia in Ano-Rectal Surgery|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Placebo Comparator: Control Arm
In pre-op, the subject is administered four placebo pills PO containing confectioners sugar, which are matched in color, size, and shape to the active pills.
Experimental: Experimental Arm
In pre-op, the subject is administered four pills PO containing a total of 1000 mg of acetaminophen and 600 mg of gabapentin, which are matched in color, size, and shape to the placebo pills.
Other Name: Neurontin, Gralise, Fanatrex
Prior to the incision in the operating room, the anesthesiologist administers 0.15 mg/kg of ketamine IV push in patients randomized to the experimental arm, only.
Other Name: Ketalar
Other Name: Tylenol, panadol, mapap, ofirmev, tempra
Prior to the incision in the operating room, the anesthesiologist administers 8 mg of dexamethasone IV push in patients randomized to the experimental arm, only.
Other Name: Decadron,
- Postoperative pain [ Time Frame: End of surgery up to 7 days postoperatively ]Pain will be evaluated using numerical rating scales at specified intervals from the end of surgery up to 7 days postoperatively and mailed back to the investigators. The pain levels will be compared between groups.
- Narcotic consumption [ Time Frame: End of surgery up to 7 days postoperatively ]Narcotic consumption will be recorded by the subject on medication diaries attached to the respective numerical rating scale. This helps to identify at which time point the patient took a narcotic. This will be compared between groups.
- Interval for rescue pain medication [ Time Frame: End of surgery up to 7 days postoperatively ]On the aforementioned medication diaries, the patient will record when he or she first needed break through pain medication (i.e. the narcotic prescribed) beyond the scheduled pain medicines. This will help us evaluate the interval between end of the operation and first need for breakthrough pain medication. This number will be compared between groups.
- Further pain requirements [ Time Frame: End of surgery up to 7 days postoperatively ]By examining the medication diaries, we will be able to evaluate if there were patients who required more than the scheduled pain medications and breakthrough narcotic. This number will be compared between groups.
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): NCT02402543
|United States, Vermont|
|University of Vermont Medical Center|
|Burlington, Vermont, United States, 05401|
|University of Vermont Medical Center Fanny Allen Campus|
|Colchester, Vermont, United States, 05446|