Perianal Nerval Block in Proctological Interventions

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Fissure in Ano; Perianal Fistula; Hemorrhoids

Treatments: Drug: 40 mL Ropivacain 0.5%; Drug: Placebo 40 mL Saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT03405922

Perianal block in proctology

Details and patient eligibility

About

The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

Full description

The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

All patients will undergo surgery under general or spinal anesthesia. At the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. The experimental group will receive a local anesthetics and the control group a normal saline injection. All injections will be perianal, peripheral to the external anal sphincter.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures.
• Age of 18 or above

Exclusion criteria

• age under 18.
• Patients unable to understand an informed consent.
• Emergency operations
• Pregnant women.
• Patients with acute perianal infection.
• Patients allergic to any component of the local anesthetic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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166 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo 40 mL Saline 0.9%

Treatment:

Drug: Placebo 40 mL Saline 0.9%

Ropivacain

Active Comparator group

Description:

40 mL Ropivacain 0.5%

Treatment:

Drug: 40 mL Ropivacain 0.5%