Hemorrhoidectomy Clinical Trial
Official title:
Preemptive Analgesia for Hemorrhoidectomy
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinic of Colorectal and Minimally Invasive Surgery | Moscow |
Lead Sponsor | Collaborator |
---|---|
Russian Society of Colorectal Surgeons |
Russian Federation,
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 |
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