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Preemptive Analgesia for 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: NCT04361695
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Russian Society of Colorectal Surgeons

Brief Summary:
Preemptive analgesia with the spinal anesthesia allows to decrease pain in hemorrhoidectomy postoperative period. The purpose of this study is to assess the effectiveness of the use of preemptive analgesia with spinal anesthesia to decrease postoperative pain and the amount of used analgesics including opioids.

Condition or disease Intervention/treatment Phase
Hemorrhoidectomy Procedure: Hemorrhoidectomy Drug: Ketoprophenum Drug: Placebo Not Applicable

Detailed Description:

Hemorrhoidectomy, as has being demonstrated to be an effective method of treatment for stage III-IV hemorrhoidal disease. However it is associated with intense postoperative pain that requires the use of multimodal analgesia. Inadequate pain control leads to the prolongation of admission, increasing the consumption of opioid analgesics, patients dissatisfaction with treatment.

According to international guidelines of pain management the target level of postoperative pain should be 3-4 or less Visual Analogue Score (VAS) points. The multimodal analgesia including Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), acetaminophen and local anaesthetics are used to reach this aim.

However, there are data on effectiveness of preemptive analgesia in anorectal surgery. Preemptive analgesia allows decreasing pain in postoperative period after hemorrhoidectomy.

Ketoprophenum is used as an preemptive analgetic agent 1 hour prior to procedure.

The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the use of preemptive analgesia with Ketoprophenum 10 mg 2 hours before procedure per os with spinal anaesthesia to decrease postoperative pain and the amount of used analgesics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Preemptive Analgesia for Hemorrhoidectomy
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : August 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketoprophenum
A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery
Procedure: Hemorrhoidectomy
The patient receives spinal anaesthesia and is placed in lithotomy position. A complex of external and internal haemorrhoid or internal haemorrhoid only is excised with monopolar electrocautery or bipolar electrosurgery device. Haemorrhoid pedicle is tied with absorbable polyfilament suture. One, two or three nodes can be removed per a procedure.

Drug: Ketoprophenum
Ketoprophenum

Placebo Comparator: Placebo
A tablet containing starch is taken per os 2 hours before surgery
Procedure: Hemorrhoidectomy
The patient receives spinal anaesthesia and is placed in lithotomy position. A complex of external and internal haemorrhoid or internal haemorrhoid only is excised with monopolar electrocautery or bipolar electrosurgery device. Haemorrhoid pedicle is tied with absorbable polyfilament suture. One, two or three nodes can be removed per a procedure.

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. The frequency of opioid analgesics usage [ Time Frame: 0-7 days postoperatively ]
    The frequency of opioid administration per day


Secondary Outcome Measures :
  1. Severity of pain [ Time Frame: 6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day ]
    The severity of the pain syndrome before defecation and after defecation reported by the patient according to Visual Analogue Score (VAS), where 0 - the minimum pain, 10 - the worst pain.

  2. Duration of other analgesics usage [ Time Frame: 0-7 days postoperatively ]
    The duration in days of systemic and topical analgesics usage

  3. Frequency of other analgesics usage [ Time Frame: 0-7 days postoperatively ]
    Times per day of systemic and topical analgesics usage

  4. Re-admission rate [ Time Frame: 30 days postoperatively ]
    The rate of patients who were re-admitted due to refractory pain

  5. Overall quality of life [ Time Frame: 7th and 30th days postoperatively ]
    Assessed with patient-reported questionnaire Short Form 36 (SF-36). A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability

  6. Returning to work [ Time Frame: 30 days postoperatively ]
    The period of time in days from the operation to returning to work

  7. The rate of early postoperative complications [ Time Frame: 0-30 days postoperatively ]
    The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent.
  2. Patients over 18 years.
  3. Symptomatic grade III-IV haemorrhoids.
  4. Planned surgery: Milligan-Morgan hemorrhoidectomy

Exclusion Criteria:

  1. Patient's refusal to participate in the study.
  2. Pregnancy.
  3. Contraindication or technical inability to perform subarachnoid anaesthesia.
  4. Decompensated somatic diseases

Information from the National Library of Medicine

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): NCT04361695


Contacts
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Contact: Tatiana Garmanova, PhD +79773429249 garmanova@kkmx.ru
Contact: Daniil Markaryan, PhD makaryan@kkmx.ru

Locations
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Russian Federation
Clinic of Colorectal and Minimally Invasive Surgery Recruiting
Moscow, Russian Federation, 119435
Contact: Tatiana Garmanova, PhD    +79773429249    garmanova@kkmx.ru   
Contact: Daniil Markaryan, PhD       markaryan@kkmx.ru   
Sponsors and Collaborators
Russian Society of Colorectal Surgeons
Investigators
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Principal Investigator: Petr Tsarkov, Professor Russian Society of Colorectal Surgeons
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Responsible Party: Russian Society of Colorectal Surgeons
ClinicalTrials.gov Identifier: NCT04361695    
Other Study ID Numbers: 10
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No