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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 40 mL Saline 0.9% |
|
| Ropivacain | Active Comparator | 40 mL Ropivacain 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo 40 mL Saline 0.9% | Drug | Injection of 40 mL 0.9% saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life assessed by questionnaire | Quality of Life assessed by questionnaire | 2 weeks post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Steinemann | St:Claraspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Claraspital | Basel | 4016 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32187663 | Derived | Rotigliano N, Fuglistaler I, Guenin MO, Dursunoglu GB, Freiermuth D, von Flue M, Steinemann DC. Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT). Br J Surg. 2020 Jul;107(8):960-969. doi: 10.1002/bjs.11520. Epub 2020 Mar 18. |
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 40 mL Ropivacain 0.5% |
| Drug |
Ropivacaine Hcl 0.5% Injection 40 mL |
|
| D004066 |
| Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017670 |
| Sodium Compounds |