Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery.

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Unknown; Phase 4

Conditions: Proctological Surgery

Treatments: Drug: Levobupivacaine; Drug: Clonidine; Drug: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT04530903

B076202042809

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Group Clonidine

Experimental group

Description:

Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side.

Treatment:

Drug: Clonidine

Drug: Levobupivacaine

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: NaCl 0.9%

Drug: Levobupivacaine