Difference in Occurrence of Rebound Pain in Patients Undergoing Surgery Under Popliteal Block or Ankle Block

NCT05734469 | Unknown

• 1 other identifier: 2022/22SEP/352
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a monocentric, comparative prospective randomized controlled trial. Patients will be randomised into 2 groups and will receive either a sciatic popliteal nerve block or an ankle block (single dose locoregional block injection before the surgery) for elective forefoot surgery in addition to general anaesthesia. The study will:

• Compare the occurrence of rebound pain and its recovery between a peripheral nerve block of the popliteal sciatic nerve and an ankle block in patients undergoing lower limb (forefoot) bone surgery under general anaesthesia combined with a PNB achieved in preoperative single injection.
• To identify the role of the type of nerve fibers anesthetized and the local inflammatory process in rebound pain development.
• Assessing the amount of the local sympathetic block induced by the locoregional anesthesia could be used a non-invasive predictive indicator of the occurrence of rebound pain depending on the nerve fibers involved (purely sensitive versus sensitive and motor).

Conditions

Anesthesia, Regional; Anesthesia and Analgesia

Outcome Measures

Primary Outcomes (1)

• Difference in the occurrence of rebound pain according to the type of PNB

  The investigators wished to prospectively evaluate and compare the incidence of the occurrence of RP, in the context of popliteal sciatic nerve PNB (sensory-motor block) and in the context of distal ankle PNB (pure sensory block). RP was defined in this study as severe pain with a Numerating Rating Scale of Spasticity (NRS) score ≥ 7/10 within the first 24 hours after performing the PNB.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• The importance of the local sympathetic block induced by the locoregional anesthesia as well as the type of anesthetized nerve fibers in the rebound pain process.

  Through study completion, an average of 1 year

• Predictors of Pain Rebound in the Context of Forefoot Surgery with BNP

  Through study completion, an average of 1 year

Study Arms (2)

Popliteal sciatic nerve block

OTHER

A local anesthetic solution of 30ml of ROPIVACAINE 0,5% (4mg/kg maximum) will be used for the popliteal sciatic nerve block (popliteal sciatic, saphenous) by real-time ultrasound guidance (associated with a standardized general anesthesia)

Other: Forefoot bone surgery

Ankle block

OTHER

A maximum solution of 15ml of ROPIVACAINE 0. 5%( 4mg/kg maximum) for the ankle block (saphenous, superficial peroneal, deep peroneal and tibial nerves) by real-time ultrasound guidance (associated with a standardized general anesthesia)

Other: Forefoot bone surgery

Interventions

Forefoot bone surgery OTHER

Elective forefoot bone surgery under popliteal sciatic nerve

Popliteal sciatic nerve block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any surgery of the bones of the lower limbs performed as part of a PNB associated with general anaesthesia after lower limb bone surgery
• Patient aged between 18 and 75 years old.

You may not qualify if:

• refusal to participate
• contraindication to the use of local anesthetics
• contraindication to the use of general anesthesia
• contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
• cognitive disorders
• inability to answer perioperative questionnaires (language problem).

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Related Publications (10)

• Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.

  PMID: 33390261 BACKGROUND

• Streb T, Schneider A, Wiesmann T, Riecke J, Schubert AK, Dinges HC, Volberg C. [Rebound pain-From definition to treatment]. Anaesthesiologie. 2022 Aug;71(8):638-645. doi: 10.1007/s00101-022-01120-z. Epub 2022 May 5. German.

  PMID: 35513729 BACKGROUND

• Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available.

  PMID: 33551124 BACKGROUND

• Touil N, Pavlopoulou A, Barbier O, Libouton X, Lavand'homme P. Evaluation of intraoperative ketamine on the prevention of severe rebound pain upon cessation of peripheral nerve block: a prospective randomised, double-blind, placebo-controlled study. Br J Anaesth. 2022 Apr;128(4):734-741. doi: 10.1016/j.bja.2021.11.043. Epub 2022 Feb 23.

  PMID: 35219449 BACKGROUND

• Sort R, Brorson S, Gogenur I, Nielsen JK, Moller AM. Rebound pain following peripheral nerve block anaesthesia in acute ankle fracture surgery: An exploratory pilot study. Acta Anaesthesiol Scand. 2019 Mar;63(3):396-402. doi: 10.1111/aas.13290. Epub 2018 Nov 8.

  PMID: 30411313 BACKGROUND

• Sort R, Brorson S, Gogenur I, Hald LL, Nielsen JK, Salling N, Hougaard S, Foss NB, Tengberg PT, Klausen TW, Moller AM. Peripheral nerve block anaesthesia and postoperative pain in acute ankle fracture surgery: the AnAnkle randomised trial. Br J Anaesth. 2021 Apr;126(4):881-888. doi: 10.1016/j.bja.2020.12.037. Epub 2021 Feb 2.

  PMID: 33546844 BACKGROUND

• Jen TTH, Ke JXC, Wing KJ, Denomme J, McIsaac DI, Huang SC, Ree RM, Prabhakar C, Schwarz SKW, Yarnold CH. Development and internal validation of a multivariable risk prediction model for severe rebound pain after foot and ankle surgery involving single-shot popliteal sciatic nerve block. Br J Anaesth. 2022 Jul;129(1):127-135. doi: 10.1016/j.bja.2022.03.030. Epub 2022 May 12.

  PMID: 35568510 BACKGROUND

• Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. doi: 10.1097/BOT.0b013e3182638b25.

  PMID: 22732860 BACKGROUND

• Yamada T, Hasegawa-Moriyama M, Kurimoto T, Saito T, Kuwaki T, Kanmura Y. Peripheral Nerve Block Facilitates Acute Inflammatory Responses Induced by Surgical Incision in Mice. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):593-600. doi: 10.1097/AAP.0000000000000458.

  PMID: 27547899 BACKGROUND

• Tighe PJ, Elliott CE, Lucas SD, Boezaart AP. Noninvasive tissue oxygen saturation determined by near-infrared spectroscopy following peripheral nerve block. Acta Anaesthesiol Scand. 2011 Nov;55(10):1239-46. doi: 10.1111/j.1399-6576.2011.02533.x. Epub 2011 Sep 26.

  PMID: 22092129 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nassim TOUIL, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nassim TOUIL, MD

CONTACT

+3227641888; nassim.touil@saintluc.uclouvain.be

Patricia LAVAND'HOMME, MD, PhD

CONTACT

+3227641897; patricia.lavandhomme@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 21, 2023
• Study Start: February 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: March 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share