Proctological Surgery Clinical Trial
Official title:
Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery: Pilot Study, Prospective
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | January 1, 2021 |
| Est. primary completion date | January 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Saint-Pierre | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Saint Pierre |
Belgium,
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* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |