Hemorrhoidectomy Clinical Trial
— IRENOfficial title:
Intraoperative Use of Perineal Block for Hemorrhoidectomy
NCT number | NCT04288349 |
Other study ID # | 1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 20, 2020 |
Est. completion date | May 30, 2020 |
Perineal block with the anesthesia of the pudendal nerve`s terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia The purpose of this study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 30, 2020 |
Est. primary completion date | May 29, 2020 |
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 hemorrhoids. 4. Planned surgery: Milligan-Morgan hemorrhoidectomy. Exclusion Criteria: 1. Patient`s refuse to participate in the study. 2. Pregnancy. 3. ?ontraindications or technical inability to perform subarachnoid anesthesia. 4. Decompensated somatic diseases. 5. Inflammation of the perianal region. |
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 rate of opioid analgesics usage | The need to use opioid analgesics. | 1 day - 2 weeks | |
Secondary | systemic analgesics usage | The duration and frequency of systemic analgesics usage, including opioid and topical local anesthetics in early postoperative period. The assessment of the required amount and frequency of NSAIDs (nonsteroidal anti-inflammatory drugs) usage in the first 24 hours, then - daily up to 7 days | 1 day - 2 weeks | |
Secondary | The duration of painless period after surgery | the time from the moment of the blockade to the need of intake the first dose of analgesics. | 1 day - 1 week | |
Secondary | re-admission | The need for re-admission after operation | 1 day - 1 month | |
Secondary | quality of life with SF-36 questionnaire | The assessment of quality of life after surgery using the SF-36 questionnaire (The Short Form-36). Scale evaluates physical and mental status after operation. | 1 day - 1 month | |
Secondary | The timing of returning to work. | The period between surgery and returning to normal work | 1 day - 1 month | |
Secondary | early postoperative complications | Assessment of early postoperative complications (bleeding, retention of urine, infectious complications). | 1 day - 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT06403774 -
Bowel Preparation Before Hemorrhoidectomy
|
N/A | |
Recruiting |
NCT04361695 -
Preemptive Analgesia 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 |