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NCT02402543 · ClinicalTrials.gov registry record · NA

Pre-Emptive Analgesia in Ano-Rectal Surgery

A NA study, sponsored by University of Vermont.

Completed
Registry status
NA
Development phase
90
Enrollment target

NCT02402543: Completed NA study, sponsored by University of Vermont.

NCT02402543 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02402543, a NA study, has completed, sponsored by University of Vermont.

COMPLETED
Registry status
NA
Development phase
90 participants
Enrollment target

Study Summary

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 m

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Acetaminophen
  • DRUG Ketamine
  • DRUG Dexamethasone
  • DRUG Gabapentin

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2014-06
Est. Completion 2017-05
Phase NA
University of Vermont

162 total trials

What the finished NCT02402543 record still lists

NCT02402543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT02402543 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02402543 about?

NCT02402543 is a clinical study titled "Pre-Emptive Analgesia in Ano-Rectal Surgery". 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 ...

What is the current status of trial NCT02402543?

This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2014-06. Estimated completion is 2017-05.

What interventions are being tested in trial NCT02402543?

The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Ketamine (DRUG), Dexamethasone (DRUG), Gabapentin (DRUG).

Who is sponsoring clinical trial NCT02402543?

This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02402543's enrollment target sits among peer trials

90 941st of 2000 higher than 1,029 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02402543, the US trial registry maintained by the National Library of Medicine. NCT02402543 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.