Fissure in Ano, Hemorrhoids, Perianal Fistula
Conditions
Brief summary
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
Detailed 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.
Interventions
DRUGPlacebo 40 mL Saline 0.9%
Injection of 40 mL 0.9% saline
DRUG40 mL Ropivacain 0.5%
Ropivacaine Hcl 0.5% Injection 40 mL
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 24 hours post-surgery | Postoperative Pain assessed by visual analogue scale (max. 10, min.0 points, range: 0-10; 0 = no pain at all, 10 = worst pain ever experienced) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life assessed by questionnaire | 2 weeks post-surgery | Quality of Life assessed by questionnaire |
Countries
Switzerland
Outcome results
None listed