IREN: IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

Sponsor

Russian Society of Colorectal Surgeons (Other)

Overall Status

Unknown status

CT.gov ID

NCT04288349

Collaborator

(none)

100

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoidectomy Pudendal Nerve	Procedure: perineal block with usage of one of solutions Drug: epinephrine + ropivacaine +saline Drug: epinephrine + saline	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Randomization of the patients included in the study was performed before surgery. Patients were being randomly divided into two groups. All patients getting subarachnoid anesthesia. Perineal block using solution of ropivocaine and epinephrine for the first group was performed and placebo with epinephrine - for the second group. A researcher who does not participate in the surgery and does not contact with patients at all perioperative stages performs randomization and prepares a solution block. Neither the patient nor the operating surgeon and the doctors who register the results of the treatment are not informed about the anesthesia used in each case. The probability of introduction to each group is 50%. The number of patients in both groups equally and is 50 people.

Primary Purpose:

Treatment

Official Title:

Intraoperative Use of Perineal Block for Hemorrhoidectomy

Actual Study Start Date :

Feb 20, 2020

Anticipated Primary Completion Date :

May 29, 2020

Anticipated Study Completion Date :

May 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: epinephrine + ropivacaine +saline 1% epinephrine solution + 30 ml of 1% ropivacaine solution diluted with 20 ml of 0.9% saline for achievement a 0.75% anesthetic solution in a ratio of 1: 200 000	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
Placebo Comparator: epinephrine + saline 1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.	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 + saline epinephrine + saline

Arm

Intervention/Treatment

Active Comparator: epinephrine + ropivacaine +saline

1% epinephrine solution + 30 ml of 1% ropivacaine solution diluted with 20 ml of 0.9% saline for achievement a 0.75% anesthetic solution in a ratio of 1: 200 000

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

Placebo Comparator: epinephrine + saline

1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.

Procedure: perineal block with usage of one of solutions

Drug: epinephrine + saline

epinephrine + saline

Outcome Measures

Primary Outcome Measures

The rate of opioid analgesics usage [1 day - 2 weeks]
The need to use opioid analgesics.

Secondary Outcome Measures

systemic analgesics usage [1 day - 2 weeks]
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
The duration of painless period after surgery [1 day - 1 week]
the time from the moment of the blockade to the need of intake the first dose of analgesics.
re-admission [1 day - 1 month]
The need for re-admission after operation
quality of life with SF-36 questionnaire [1 day - 1 month]
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.
The timing of returning to work. [1 day - 1 month]
The period between surgery and returning to normal work
early postoperative complications [1 day - 1 month]
Assessment of early postoperative complications (bleeding, retention of urine, infectious complications).