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

September 16, 2020 updated by: Centre Hospitalier Universitaire Saint Pierre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group Clonidine
Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side.
Drug: Clonidine
75 µg (0.5mL) per injection site
Other Names:
  • Catapressan
Drug: Levobupivacaine
0.25% (10 ml) per injection site
Other Names:
  • Chirocaine
PLACEBO_COMPARATOR: Control
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.
Drug: Levobupivacaine
0.25% (10 ml) per injection site
Other Names:
  • Chirocaine
Drug: NaCl 0.9%
Nacl 0.9% (0.5ml) per injection site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Dose of Opioids consumed in the intraoperative period
Time Frame: 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).
up to 24 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Dose of tramadol consumed in the recovery room
Time Frame: 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)
up to 24 hours post-surgery
Total consumption of tramadol in post-operative period
Time Frame: 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)
up to 24 hours post-surgery
Need for tramadol administration per patient during the first 24 hours
Time Frame: up to 24 hours post-surgery
Number of Tramadol dose requested by the patient during the first 24 hours
up to 24 hours post-surgery
Total Dose of piritramide consumed in the recovery room
Time Frame: 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)
up to 24 hours post-surgery
Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU)
Time Frame: 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)
Total consumption of paracetamol in post-operative period
Time Frame: 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)
up to 24 hours post-surgery
Total consumption of diclofenac in post-operative period
Time Frame: 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)
up to 24 hours post-surgery
Time before First Use of Rescue Analgesic
Time Frame: 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)
up to 24 hours post-surgery
Post-operative Pain as assessed by Visual Analog Scale
Time Frame: 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)
up to 24 hours post-surgery
Patient satisfaction
Time Frame: 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.
up to 24 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

  • Principal Investigator: Myriam Suball, MD, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
  • Principal Investigator: Marzia Gambassi, MD, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 9, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (ACTUAL)

August 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B076202042809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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