A Phase 4 interventional study of Placebo 40 mL Saline 0.9% and 40 mL Ropivacain 0.5% in Perianal Fistula, Fissure in Ano and Hemorrhoids, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
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.
84 studies on the registry are indexed under Fissure in Ano; 16 are open to participants now.
This study's enrollment of 166 is above the median of 99 across 65 interventional studies indexed under Fissure in Ano.
Browse Fissure in Ano studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo 40 mL Saline 0.9%
Drug: Placebo 40 mL Saline 0.9%
40 mL Ropivacain 0.5%
Drug: 40 mL Ropivacain 0.5%
Injection of 40 mL 0.9% saline
Ropivacaine Hcl 0.5% Injection 40 mL
Postoperative Pain
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)
Time frame: 24 hours post-surgery
Quality of Life assessed by questionnaire
Quality of Life assessed by questionnaire
Time frame: 2 weeks post-surgery
Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →