Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery.

Study Overview
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Brief Summary
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Proctological surgery represents a short duration surgery performed in ambulatory, which causes significant post-operative pain. Post-operative pain resulting from proctological surgery is greater than 5 on the Visual Analog Scale (VAS) within the first 24 hours and it revives during the first defecation. The ideal pain management procedures are based on the multimodal analgesia model, based in turn on the combination of products and / or techniques to improve the quality of analgesia, reduce the side effects linked to the use of opioids, reduce responses to surgical stress, reduce postoperative recovery and allow rapid rehabilitation of the patient. The aim of our study is to investigate whether clonidine combined with levobupivacaine in the pudendal block reduce the total consumption of opioids in proctological surgery.

Official Title
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Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery: Pilot Study, Prospective

Conditions
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Proctological Surgery

Intervention / Treatment
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* Drug: Clonidine
* Drug: Levobupivacaine
* Drug: NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Signature of informed consent Exclusion Criteria: Refusal to participate ; Allergy to either local anaesthetics or clonidine; Local infectious pathologies (e.g. acute ano-perineal suppuration) Pregnancy Breastfeeding Severe bradyarrhythmia due to sinus node disease or second and third degree atrioventricular block Severe depressive condition Severe coronary artery disease Raynaud's disease Heart failure Obliterating thromboangiitis Epilepsy Spinal anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Clonidine<br>Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side. | Drug: Clonidine<br>* 75 µg (0.5mL) per injection site<br>* Other names: Catapressan;Drug: Levobupivacaine<br>* 0.25% (10 ml) per injection site<br>* Other names: Chirocaine;|
| Placebo Comparator: Control<br>Group Control will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine per side; 0.5 ml of 0.9% NaCl will be added to each syringe to homogenise the volume in order to remain blind. | Drug: Levobupivacaine<br>* 0.25% (10 ml) per injection site<br>* Other names: Chirocaine;Drug: NaCl 0.9%<br>* Nacl 0.9% (0.5ml) per injection site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Dose of Opioids consumed in the intraoperative period | Total consumption of sufentanyl during the intraoperative period (in micrograms). The administration of sufentanyl depends on the change of physiological parameters (augmentation of 20% of blood pressure and/or cardiac frequency). | up to 24 hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Dose of tramadol consumed in the recovery room | In the recovery room, dose of tramadol (in milligrams, intravenous administration). The administration of tramadol depends on Visual Analogic Pain Score (VAS>4) (scale = 0 no pain; 10 = worst pain imaginable) | up to 24 hours post-surgery | 
| Total consumption of tramadol in post-operative period | Total consumption of tramadol from the exit of the recovery room to the day after the surgery based on Visual Analogic Pain Score >4 (scale = 0 no pain; 10 = worst pain imaginable). Tramadol (dose in milligrams, oral administration) | up to 24 hours post-surgery | 
| Need for tramadol administration per patient during the first 24 hours | Number of Tramadol dose requested by the patient during the first 24 hours | up to 24 hours post-surgery | 
| Total Dose of piritramide consumed in the recovery room | In the recovery room, dose of piritramide (in milligrams, intravenous administration). The administration of piritramide depends on Visual Analogic Pain Score (VAS>4) (scale = 0 no pain; 10 = worst pain imaginable) | up to 24 hours post-surgery | 
| Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU) | Number of Piritramid dose requested by the patient during the hospitalization in Post Anesthesia Care Unit (PACU) | during the hospitalization in Post Anesthesia Care Unit (PACU) | 
| Total consumption of paracetamol in post-operative period | Total consumption of paracetamol from the exit of the recovery room to the day after the surgery based on Visual Analogic Pain Score >4 (scale = 0 no pain; 10 = worst pain imaginable). Paracetamol (dose in grams, oral administration) | up to 24 hours post-surgery | 
| Total consumption of diclofenac in post-operative period | Total consumption of diclofenac from the exit of the recovery room to the day after the surgery based on Visual Analogic Pain Score >4 (scale = 0 no pain; 10 = worst pain imaginable). Diclofenac (dose in milligrams, oral administration) | up to 24 hours post-surgery | 
| Time before First Use of Rescue Analgesic | Time between the completion of the block and the first post-operative administration of rescue analgesics (Tramadol and/or Piritramide on request) | up to 24 hours post-surgery | 
| Post-operative Pain as assessed by Visual Analog Scale | Post-operative Pain levels will be determined every 15 minutes in the recovery room, then every hour until discharge and on Day 1 at home; Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable) | up to 24 hours post-surgery | 
| Patient satisfaction | Level of satisfaction assessed on a 5-point scale (from 1 to 5): 1 not satisfied, 2 not very satisfied, 3 moderately satisfied, 4 satisfied, 5 very satisfied. | up to 24 hours post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative Pain, Pudendal Block, Clonidine, Levobupivacaine