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HemorrhoidsPEAARSNCT02402543

Pre-Emptive Analgesia in Ano-Rectal Surgery

A study testing Gabapentin, Ketamine and Acetaminophen in people with Hemorrhoids and Fissure in Ano, run by University of Vermont at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhoids, Fissure in Ano, Rectal Fistula
What is being tested?
Gabapentin, Ketamine and Acetaminophen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesUnited States
Study dates
Jun 2014to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients having anal fistula repairs for anal fistulas recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses OR
  • Patients having anal sphincterotomies for chronic anal fissures recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses OR
  • Patients having hemorrhoidectomies for hemorrhoids recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses OR
  • Patients having anal condyloma excisions for anal condylomas recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses
  • Patients undergoing these surgeries must be American Society of Anesthesiologists (ASA) Physical Status Classification System scores of I (normal, healthy patient), II (patient with mild, systemic disease), or III (patients with more significant disease)

Who cannot join

  • Allergies to any study medications;
  • Patient history and chart review for existence of hepatic or renal failure;
  • Chronic pain syndrome;
  • Inability to understand or utilize the Numerical Rating Scale (NRS);
  • Pregnancy;
  • Patients currently on gabapentin, pregabalin or narcotics
  • Patients taking chronic steroids, unable to taper off before surgery

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont Medical Center Fanny Allen Campus

    Colchester, Vermont, 05446

Other trials in United States

About this study

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.

Read the detailed description

Despite advances in pain medicine, postoperative pain control remains problematic with over 5% of patients experiencing severe pain despite standard of care pain management, and is a frequently cited reason for delayed discharge in outpatient procedures [1]. In anorectal surgeries, almost all patients experience mild-to-moderate postoperative subjective pain [2], and as an example 12% of patients report severe postoperative pain during their recovery from hemorrhoidectomy surgery [3]. Control of postoperative pain is an important goal. Preemptive analgesia is a technique that involves premedicating the patient with a regimen of medications designed to target different points in the pain cascade to prevent central and peripheral sensitization to pain, also known as "wind-up" [4]. The activation of N-methyl-D-aspartate (NMDA) receptors is an identified process that occurs in central sensitization after a noxious stimulus. By pharmacologically blocking these receptors, it may be possible to prevent or suppress the degree of central sensitization, which can prevent the hyperalgesic, or exaggerated pain response, that some patients experience [5]. Peripheral sensitization is a similar concept and occurs due to noxious stimuli in the periphery, such as a surgical incision. This type of sensitization has typically been prevented with regional anesthesia and by increasing the nociceptive threshold of the neurons with different medications.

Preemptive analgesia focusing on the effect of single medications on pain control has shown promising results, however some studies appear to lend themselves to practice [6-19] better than others [20-26]. On the other hand, multimodal pain control regimens might be more promising. A search of the literature reveals that preemptive pharmacological blockade of wind up has been effectively used in both surgical and nonsurgical patients (burn patients [27]). In patients undergoing hip arthroplasty, or hip replacement surgery, under general anesthesia, blocking both central and peripheral sensitization results in significantly decreased subjective pain, and a trend toward less postoperative use of analgesics [28]. Similarly, patients undergoing multilevel spinal surgeries [29] and those undergoing prostatic surgery [30] under general anesthesia consume less postoperative analgesics when undergoing multimodal preemptive pain control by blocking both sensitization pathways. Finally, preemptive central sensitization blockade alone has been used with trends in improved pain control for gynecological surgeries under both general [31] and regional anesthesia [32]. The preemptive use of such medications has not been studied for anorectal surgeries and it is what we are suggesting in this study. Most pain control studies in the literature focus on postoperative rather than preemptive medication regimens for pain management [33-35], and there is no current standard of care as to an effective regimen. The studies effective in decreasing postoperative pain in other surgical contexts, such as for patients undergoing hip arthroplasty, have used the same combination of medications proposed for the Treatment Group. Finally, the added benefit of the anorectal patient population in terms of the putative decreased use of opioids for postoperative pain control revolves around the opioid-related adverse effects on bowel function. In fact, return of bowel movements and regularity is one criterion for healing after surgery.

Based on this existing literature, we propose in our current study to preemptively block both central sensitization through the use of intravenous ketamine perioperatively and peripheral sensitization through the use of intravenous dexamethasone administered perioperatively and oral gabapentin and acetaminophen administered preoperatively. Ketamine is a noncompetitive NMDA receptor antagonist acting centrally in the dorsal horn of the spinal cord to decrease the release of glutamate, reducing the transmission of pain messages centrally [36]. Intravenous ketamine has been shown to decrease 24-hour opioid requirements, and preemptive use of ketamine was part of the medications used in most of the studies mentioned in the literature review above. As it currently stands, use of ketamine in anorectal surgeries as an added analgesic has been proven safe. Among Nigerian surgery patients having received regional anesthesia and preemptive ketamine, postoperative pain levels have been shown to decrease, however it is unclear if this patient cohort included anorectal surgery patients [37]. No other studies have been conducted regarding postoperative pain in these patients [38]. By utilizing ketamine as one of the medications in our study, we hope to show similar effects resulting in patients experiencing decreased postoperative pain after common anorectal surgeries.

Dexamethasone is a corticosteroid with potent anti-inflammatory effects that is also used as an anti-emetic. The proposed mechanism of action of dexamethasone is not completely known, but it is thought to involve inhibition of prostaglandin synthesis and an increased release of endorphins. Endorphins are endogenous peptides that bind to pain receptors in the body to decrease pain. In addition, endorphins can facilitate mood elevation and a sense of well-being. Intravenous dexamethasone was part of the medications used in studies mentioned in the literature review above. One study investigating the prophylactic use of dexamethasone for its anti-emetic properties, in combination with sevoflurane, a general anesthetic, during anorectal surgery found a significant decrease in maximal postoperative VAS pain scores in patients administered dexamethasone compared to those given placebos [2]. The use of dexamethasone as a preemptive analgesic has not been fully studied in anorectal surgery patients.

Gabapentin acts by binding to receptors on voltage-gated calcium channels on presynaptic nerves, reducing the entry of calcium into presynaptic nerve terminals. The subsequent decreased release of excitatory neurotransmitters such as glutamate, aspartate, substance P, and norepinephrine into the synaptic cleft is linked to a diminished postsynaptic transmission of neural pain messages [36]. It is usually used for neuropathic pain control, and has been used in some of the studies mentioned in the literature review above. A systemic review of the perioperative effects of gabapentin found that it is an effective means of reducing post-operative pain, opioid consumption, and opioid-related adverse effects in surgical patients. In fact, administration of a single dose of gabapentin was found to be equivalent to a reduction of 30 mg of morphine in the first 24 hours after surgery [39]. No studies have been conducted, to the best of our knowledge, regarding preemptive use of gabapentin in anorectal surgeries.

Local, peripheral sensitization has also been minimized through the use of non-steroidal anti-inflammatory drugs (NSAIDs) due to the decreased production of certain molecules such as prostaglandins and kinins. The enzyme required to make these molecules is blocked by acetaminophen and NSAIDs, which is why acetaminophen is included in this study in hopes of demonstrating better pain control among anorectal surgery patients. Acetaminophen is a weak analgesic that forms the most basic component of a multimodal analgesia regimen [36]. Oral preemptive use of acetaminophen has been proven to decrease postoperative narcotic use in surgical patients [40], and has been used in some of the studies mentioned in the literature review above. A related intramuscular NSAID, namely Toradol, has been used preemptively among anorectal surgical patients with good pain control [41]. No other studies are reported in this patient population.

Of importance, the combinations of the medications used in this study have been used in other studies before with similar or higher doses and no significant differences in terms of hemodynamic variables (such as vital signs) or adverse side effects have been noted compared to control groups [31]. In fact, these medications are safely used at UVM Medical Center by the collaborating surgeons as part of their care for other surgeries such as abdominal surgeries.

*References 1-41 available upon request

Keywords
preemptive analgesia, anorectal surgery, gabapentin, neurontin, ketamine, acetaminophen, tylenol, postoperative pain, postoperative narcotic usage, dexamethasone, decadron
Medical subject headings
Hemorrhoids, Fissure in Ano, Rectal Fistula, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GabapentinDrug

    Also called Neurontin, Gralise, Fanatrex

  • KetamineDrug

    Also called Ketalar

    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.

  • AcetaminophenDrug

    Also called Tylenol, panadol, mapap, ofirmev, tempra

  • DexamethasoneDrug

    Also called Decadron,

    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.

  • PlaceboDrug

Study groups in NCT02402543
Study groupRoleWhat they receive
Control ArmPlacebo comparatorIn 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.
Receives: Drug: Placebo
Experimental ArmExperimentalIn 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.
Receives: Drug: Gabapentin; Drug: Ketamine; Drug: Acetaminophen; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain

    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.

    Measured: End of surgery up to 7 days postoperatively

Secondary outcomes (3)
  1. Narcotic consumption

    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.

    Measured: End of surgery up to 7 days postoperatively

  2. Interval for rescue pain medication

    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.

    Measured: End of surgery up to 7 days postoperatively

  3. Further pain requirements

    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.

    Measured: End of surgery up to 7 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02402543
Sponsor's protocol ID
CHRMS: M13-226
Acronym
PEAARS
Status last verified
Jan 2018
First submitted
25 Mar 2015
Last updated
16 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.

    PubMed 9322460
  • Wu JI, Lu SF, Chia YY, Yang LC, Fong WP, Tan PH. Sevoflurane with or without antiemetic prophylaxis of dexamethasone in spontaneously breathing patients undergoing outpatient anorectal surgery. J Clin Anesth. 2009 Nov;21(7):469-73. doi: 10.1016/j.jclinane.2008.11.007.

    PubMed 19914051
  • Labas P, Ohradka B, Cambal M, Olejnik J, Fillo J. Haemorrhoidectomy in outpatient practice. Eur J Surg. 2002;168(11):619-20. doi: 10.1080/11024150201680008.

    PubMed 12699098
  • MENDELL LM, WALL PD. RESPONSES OF SINGLE DORSAL CORD CELLS TO PERIPHERAL CUTANEOUS UNMYELINATED FIBRES. Nature. 1965 Apr 3;206:97-9. doi: 10.1038/206097a0. No abstract available.

    PubMed 14334366
  • Stubhaug A, Breivik H, Eide PK, Kreunen M, Foss A. Mapping of punctuate hyperalgesia around a surgical incision demonstrates that ketamine is a powerful suppressor of central sensitization to pain following surgery. Acta Anaesthesiol Scand. 1997 Oct;41(9):1124-32. doi: 10.1111/j.1399-6576.1997.tb04854.x.

    PubMed 9366932
  • Jirasiritham S, Tantivitayatan K, Jirasiritham S. Perianal blockage with 0.5% bupivacaine for postoperative pain relief in hemorrhoidectomy. J Med Assoc Thai. 2004 Jun;87(6):660-4.

    PubMed 15279345
  • Wnek W, Zajaczkowska R, Wordliczek J, Dobrogowski J, Korbut R. Influence of pre-operative ketoprofen administration (preemptive analgesia) on analgesic requirement and the level of prostaglandins in the early postoperative period. Pol J Pharmacol. 2004 Sep-Oct;56(5):547-52.

    PubMed 15591642
  • Lavand'homme P, De Kock M, Waterloos H. Intraoperative epidural analgesia combined with ketamine provides effective preventive analgesia in patients undergoing major digestive surgery. Anesthesiology. 2005 Oct;103(4):813-20. doi: 10.1097/00000542-200510000-00020.

    PubMed 16192774
  • Rockemann MG, Seeling W, Bischof C, Borstinghaus D, Steffen P, Georgieff M. Prophylactic use of epidural mepivacaine/morphine, systemic diclofenac, and metamizole reduces postoperative morphine consumption after major abdominal surgery. Anesthesiology. 1996 May;84(5):1027-34. doi: 10.1097/00000542-199605000-00003.

    PubMed 8623995
  • Kara I, Tuncer S, Erol A, Reisli R. [The effects of preemptive dexketoprofen use on postoperative pain relief and tramadol consumption]. Agri. 2011 Jan;23(1):18-21. doi: 10.5505/agri.2011.21939. Turkish.

    PubMed 21341148
  • Aida S, Yamakura T, Baba H, Taga K, Fukuda S, Shimoji K. Preemptive analgesia by intravenous low-dose ketamine and epidural morphine in gastrectomy: a randomized double-blind study. Anesthesiology. 2000 Jun;92(6):1624-30. doi: 10.1097/00000542-200006000-00020.

    PubMed 10839912
  • Zielinski J, Jaworski R, Smietanska I, Irga N, Wujtewicz M, Jaskiewicz J. A randomized, double-blind, placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast. Med Sci Monit. 2011 Oct;17(10):CR589-97. doi: 10.12659/msm.881986.

    PubMed 21959614
  • Kilickan L, Toker K. The effect of preemptive intravenous morphine on postoperative analgesia and surgical stress response. Panminerva Med. 2001 Sep;43(3):171-5.

    PubMed 11579330
  • Cai XH, Wang SP, Chen XT, Peng SL, Cao MH, Ye XJ, Yang YZ. [Comparison of three analgesic methods for postoperative pain relief and their effects on plasma interleukin-6 concentration following radical surgery for gastric carcinoma]. Nan Fang Yi Ke Da Xue Xue Bao. 2007 Mar;27(3):387-9. Chinese.

    PubMed 17426001
  • Ng WT. Re: laparoscopic repair of colonoscopic perforations. Surg laparosc endosc percutan tech. 2006;16:49-51. Surg Laparosc Endosc Percutan Tech. 2007 Feb;17(1):68-9; author reply 69. doi: 10.1097/01.sle.0000213751.23396.9e. No abstract available.

    PubMed 17318064

Questions about this trial

What is this clinical trial studying?

A study testing Gabapentin, Ketamine and Acetaminophen in people with Hemorrhoids and Fissure in Ano, run by University of Vermont at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: End of surgery up to 7 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02402543, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.

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