IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

Hemorrhoidectomy Clinical Trial

— IREN  

Official title:

Intraoperative Use of Perineal Block for Hemorrhoidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288349
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2020
• Source: Russian Society of Colorectal Surgeons
• Contact: Yuliia Churina
• Phone: +79154970361
• Email: churina[@]kkmx.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Traditionally spinal or general anesthesia is used in proctological practice. However, the number of studies about using of perianal local anesthesia, both in combination with general anesthesia and as a separate practice has been increasing recently.

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 drugs used for this have some pharmacological differences in the duration of the drug and the form of administration.

The aim of this prospective, randomized, double-blind 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hemorrhoidectomy
• Pudendal Nerve

Intervention

Procedure:
• perineal block with usage of one of solutions
Perineal block using solution of ropivocaine and epinephrine for the first group was performed. Anococcygeal ligament is infiltrated with 10 ml of the solution after the intracutaneous infiltration in 2 cm from the anus. Ten ml of the solution is injected in ischiorectal fat on each side. The needle is orienteered at the angle of 45 degrees cranially and laterally, and to the surface what allows the surgeon to anesthetize the deep branches of the pudendal nerve. In addition, 10 ml of solution is injected transdermal on the front edge of the anus with further subcutaneous infiltration on each side of the anus to provide anesthesia to the nerve branches laying more superficial. The total amount of the injected solution is 50 ml.

Drug:
• epinephrine + ropivacaine +saline
epinephrine + ropivacaine +saline
• epinephrine + saline
epinephrine + saline

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 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