Clinical trial NCT04530903: Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery.
Official title: Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery: Pilot Study, Prospective
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Proctological Surgery
Keywords: Post-operative Pain
Pudendal Block
Clonidine
Levobupivacaine
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Dose of Opioids consumed in the intraoperative period
timeFrame: up to 24 hours post-surgery
Secondary outcomes:
measure: Total Dose of tramadol consumed in the recovery room
timeFrame: up to 24 hours post-surgery
measure: Total consumption of tramadol in post-operative period
timeFrame: up to 24 hours post-surgery
measure: Need for tramadol administration per patient during the first 24 hours
timeFrame: up to 24 hours post-surgery
measure: Total Dose of piritramide consumed in the recovery room
timeFrame: up to 24 hours post-surgery
measure: Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU)
timeFrame: during the hospitalization in Post Anesthesia Care Unit (PACU)
measure: Total consumption of paracetamol in post-operative period
timeFrame: up to 24 hours post-surgery
measure: Total consumption of diclofenac in post-operative period
timeFrame: up to 24 hours post-surgery
measure: Time before First Use of Rescue Analgesic
timeFrame: up to 24 hours post-surgery
measure: Post-operative Pain as assessed by Visual Analog Scale
timeFrame: up to 24 hours post-surgery
measure: Patient satisfaction
timeFrame: up to 24 hours post-surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Saint-Pierre
Study officials:
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Panayota Kapessidou, MD,PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Myriam Suball, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Marzia Gambassi, MD
role: PRINCIPAL_INVESTIGATOR
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