NCT04530903

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

Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery: Pilot Study, Prospective

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proctological Surgery

Interventions

Type	Name	Description
DRUG	Clonidine	75 µg (0.5mL) per injection site
DRUG	Levobupivacaine	0.25% (10 ml) per injection site
DRUG	NaCl 0.9%	Nacl 0.9% (0.5ml) per injection site

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2020-08-28
• Last updated: 2020-09-17

Locations

1 site across 1 country: Belgium