Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery.
- Conditions
- Proctological Surgery
- Interventions
- Registration Number
- NCT04530903
- Lead Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Age ≥ 18 years
- Signature of informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control NaCl 0.9% 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. Group Clonidine Clonidine Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side. Control Levobupivacaine 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. Group Clonidine Levobupivacaine Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side.
- Primary Outcome Measures
Name Time Method Total Dose of Opioids consumed in the intraoperative period up to 24 hours post-surgery 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).
- Secondary Outcome Measures
Name Time Method Patient satisfaction up to 24 hours post-surgery 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.
Total consumption of tramadol in post-operative period up to 24 hours post-surgery 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)Total consumption of paracetamol in post-operative period up to 24 hours post-surgery 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)
Total consumption of diclofenac in post-operative period up to 24 hours post-surgery 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)Post-operative Pain as assessed by Visual Analog Scale up to 24 hours post-surgery 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)
Total Dose of piritramide consumed in the recovery room up to 24 hours post-surgery 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)
Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU) 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)
Time before First Use of Rescue Analgesic up to 24 hours post-surgery Time between the completion of the block and the first post-operative administration of rescue analgesics (Tramadol and/or Piritramide on request)
Total Dose of tramadol consumed in the recovery room up to 24 hours post-surgery 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)
Need for tramadol administration per patient during the first 24 hours up to 24 hours post-surgery Number of Tramadol dose requested by the patient during the first 24 hours
Trial Locations
- Locations (1)
University Hospital Saint-Pierre
🇧🇪Brussels, Belgium