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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
75 µg (0.5mL) per injection site
0.25% (10 ml) per injection site
Nacl 0.9% (0.5ml) per injection site
University Hospital Saint-Pierre
Brussels, Belgium
RECRUITINGTotal 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).
Time frame: up to 24 hours post-surgery
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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: up to 24 hours post-surgery
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