Proctological Surgery
Conditions
Keywords
Post-operative Pain, Pudendal Block, Clonidine, Levobupivacaine
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.
Interventions
DRUGClonidine
75 µg (0.5mL) per injection site
DRUGLevobupivacaine
0.25% (10 ml) per injection site
DRUGNaCl 0.9%
Nacl 0.9% (0.5ml) per injection site
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 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) |
Countries
Belgium
Contacts
Primary ContactPanayota Kapessidou, MD,PhD
Backup ContactMyriam Suball, MD
Outcome results
None listed