NCT04288349

IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

Intraoperative Use of Perineal Block for Hemorrhoidectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Russian Society of Colorectal Surgeons · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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. 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.

Conditions

• Hemorrhoidectomy
• Pudendal Nerve

Interventions

Type	Name	Description
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
DRUG	epinephrine + saline	epinephrine + saline

Timeline

• Start date: 2020-02-20
• Primary completion: 2020-05-29
• Completion: 2020-05-30
• First posted: 2020-02-28
• Last updated: 2020-05-29

Locations

1 site across 1 country: Russia