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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04361695
Other study ID # 10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 27, 2020
Est. completion date August 25, 2022

Study information

Verified date April 2020
Source Russian Society of Colorectal Surgeons
Contact Tatiana Garmanova, PhD
Phone +79773429249
Email garmanova@kkmx.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date August 25, 2022
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
Placebo

Locations

Country Name City State
Russian Federation Clinic of Colorectal and Minimally Invasive Surgery Moscow

Sponsors (1)

Lead Sponsor Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary The frequency of opioid analgesics usage The frequency of opioid administration per day 0-7 days postoperatively
Secondary Severity of pain 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. 6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day
Secondary Duration of other analgesics usage The duration in days of systemic and topical analgesics usage 0-7 days postoperatively
Secondary Frequency of other analgesics usage Times per day of systemic and topical analgesics usage 0-7 days postoperatively
Secondary Re-admission rate The rate of patients who were re-admitted due to refractory pain 30 days postoperatively
Secondary Overall quality of life 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 7th and 30th days postoperatively
Secondary Returning to work The period of time in days from the operation to returning to work 30 days postoperatively
Secondary The rate of early postoperative complications The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period 0-30 days postoperatively
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06403774 - Bowel Preparation Before Hemorrhoidectomy N/A
Recruiting NCT04288349 - IntraopeRativE Use of periNeal Block for Hemorrhoidectomy N/A
Completed NCT03938714 - Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique N/A
Active, not recruiting NCT00932542 - Eutectic Mixture for Hemorrhoidectomy Postoperative Phase 2/Phase 3
Completed NCT03848468 - Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids. N/A