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

NCT04530903 | Unknown Phase 4

• 1 other identifier: B076202042809
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Proctological Surgery

Keywords

Post-operative Pain; Pudendal Block; Clonidine; Levobupivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Total Dose of tramadol consumed in the recovery room

  up to 24 hours post-surgery

• Total consumption of tramadol in post-operative period

  up to 24 hours post-surgery

• Need for tramadol administration per patient during the first 24 hours

  up to 24 hours post-surgery

• Total Dose of piritramide consumed in the recovery room

  up to 24 hours post-surgery

• Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU)

  during the hospitalization in Post Anesthesia Care Unit (PACU)

Study Arms (2)

Group Clonidine

EXPERIMENTAL

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; Drug: Levobupivacaine

Control

PLACEBO COMPARATOR

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; Drug: NaCl 0.9%

Interventions

Clonidine DRUG

75 µg (0.5mL) per injection site

Also known as: Catapressan

Group Clonidine

Levobupivacaine DRUG

0.25% (10 ml) per injection site

Also known as: Chirocaine

Control; Group Clonidine

NaCl 0.9% DRUG

Nacl 0.9% (0.5ml) per injection site

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Signature of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

University Hospital Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Related Publications (19)

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  PMID: 15763418 BACKGROUND

• Ceulemans A, De Looze D, Van de Putte D, Stiers E, Coppens M. High post-operative pain scores despite multimodal analgesia in ambulatory anorectal surgery: a prospective cohort study. Acta Chir Belg. 2019 Aug;119(4):224-230. doi: 10.1080/00015458.2018.1500802. Epub 2018 Sep 7.

  PMID: 30189793 BACKGROUND

• Joshi GP, Neugebauer EA; PROSPECT Collaboration. Evidence-based management of pain after haemorrhoidectomy surgery. Br J Surg. 2010 Aug;97(8):1155-68. doi: 10.1002/bjs.7161.

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  PMID: 19026514 BACKGROUND

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  PMID: 22513972 BACKGROUND

• Vinson-Bonnet B.. Le bloc pudendal: technique d'analgésie postopératoire en chirurgie proctologique. Pelvi-Périnéologie 2007, 2(2):180-183.

  BACKGROUND

• Naja Z, Ziade MF, Lonnqvist PA. Nerve stimulator guided pudendal nerve block decreases posthemorrhoidectomy pain. Can J Anaesth. 2005 Jan;52(1):62-8. doi: 10.1007/BF03018582.

  PMID: 15625258 BACKGROUND

• Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.

  PMID: 10422923 BACKGROUND

• Imbelloni LE, Vieira EM, Gouveia MA, Netinho JG, Spirandelli LD, Cordeiro JA. Pudendal block with bupivacaine for postoperative pain relief. Dis Colon Rectum. 2007 Oct;50(10):1656-61. doi: 10.1007/s10350-007-0216-7.

  PMID: 17701375 BACKGROUND

• De La Arena P.. Bloc pudendal sous échographie: faisabilité et efficacité peropératoire chez l'enfant. Annales Françaises d'Anesthésie et de Réanimation 2014; A398-A403.

  BACKGROUND

• Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.

  PMID: 29205687 BACKGROUND

• Li A, Wei Z, Liu Y, Shi J, Ding H, Tang H, Zheng P, Gao Y, Feng S. Ropivacaine versus levobupivacaine in peripheral nerve block: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Apr;96(14):e6551. doi: 10.1097/MD.0000000000006551.

  PMID: 28383425 BACKGROUND

• Malav K, Singariya G, Mohammed S, Kamal M, Sangwan P, Paliwal B. Comparison of 0.5% Ropivacaine and 0.5% Levobupivacaine for Sciatic Nerve Block Using Labat Approach in Foot and Ankle Surgery. Turk J Anaesthesiol Reanim. 2018 Feb;46(1):15-20. doi: 10.5152/TJAR.2017.03411. Epub 2017 Nov 27.

  PMID: 30140496 BACKGROUND

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  PMID: 26355598 BACKGROUND

• Bernard JM, Macaire P. Dose-range effects of clonidine added to lidocaine for brachial plexus block. Anesthesiology. 1997 Aug;87(2):277-84. doi: 10.1097/00000542-199708000-00014.

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• Kelika P, Arun JM. Evaluation of clonidine as an adjuvant to brachial plexus block and its comparison with tramadol. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):197-202. doi: 10.4103/joacp.JOACP_58_13.

  PMID: 28781445 BACKGROUND

• Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.

  PMID: 19602964 BACKGROUND

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  PMID: 17720118 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Clonidine; Levobupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Panayota Kapessidou, MD,PhD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  STUDY DIRECTOR

• 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)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayota Kapessidou, MD,PhD

CONTACT

+32.2.535; pkapessi@ulb.ac.be

Myriam Suball, MD

CONTACT

+32.2.535; myriam_suball@stpierre-bru.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: August 28, 2020
• Study Start: September 9, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)