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Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.
Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age < 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving the pudendal nerve block | Experimental |
| |
| Not receiving the pudendal nerve block | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetic (ropivacaine) | Procedure | Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain on the Visual Analogue Scale (VAS) | Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain" | at 24 hours after the hemorrhoidectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain on the Visual Analogue Scale (VAS) | Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain" | at 6, 12 and 48 hours after the operation |
| Opioids Consumption |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regionale di Bellinzona e Valli | Bellinzona | 6500 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32474710 | Derived | Di Giuseppe M, Saporito A, La Regina D, Tasciotti E, Ghielmini E, Vannelli A, Pini R, Mongelli F. Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial. Int J Colorectal Dis. 2020 Sep;35(9):1741-1747. doi: 10.1007/s00384-020-03630-x. Epub 2020 May 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Receiving the Pudendal Nerve Block | Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%. |
| FG001 | Not Receiving the Pudendal Nerve Block | No ultrasound-guided pudendal block performed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Receiving the Pudendal Nerve Block | Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%. |
| BG001 | Not Receiving the Pudendal Nerve Block | No ultrasound-guided pudendal nerve block performed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Pain on the Visual Analogue Scale (VAS) | Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain" | Posted | Mean | Standard Deviation | units on a scale | at 24 hours after the hemorrhoidectomy |
|
2 years
Any adverse event related to the pudendal nerve block.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Receiving the Pudendal Nerve Block | Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%. |
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The main limitation of the study was represented by the small number of enrolled patients and larger sample are required to confirm our results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francesco Mongelli | Ospedale Regionale di Lugano | +41764706297 | francesco.mongelli@mail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2018 | May 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Randomized
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|
| Within 48 hours |
| Lenght of Hospital Stay | up to 2 weeks |
| Complications Related to the Pudendal Nerve Block | Within 6 weeks |
| Direct and Indirect Cost Analysis in Out- and In-patients | Ongoing | Within the hospital stay |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy) | Number | participants |
|
| Symptoms leading to surgery (itching, pain, bleeding, tenesmus) | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Postoperative Pain on the Visual Analogue Scale (VAS) | Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain" | Posted | Mean | Standard Deviation | score on a scale | at 6, 12 and 48 hours after the operation |
|
|
|
| Secondary | Opioids Consumption | Posted | Count of Participants | Participants | Within 48 hours |
|
|
|
| Secondary | Lenght of Hospital Stay | Posted | Mean | Standard Deviation | days | up to 2 weeks |
|
|
|
| Secondary | Complications Related to the Pudendal Nerve Block | Posted | Count of Participants | Participants | Within 6 weeks |
|
|
|
| Secondary | Direct and Indirect Cost Analysis in Out- and In-patients | Ongoing | Not Posted | Sep 2022 | Within the hospital stay | Participants |
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Not Receiving the Pudendal Nerve Block | No ultrasound-guided pudendal nerve block performed | 0 | 26 | 0 | 26 | 0 | 26 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Pain on VAS at 48 hours |
|