Anesthesia, Regional Clinical Trial
— CBFROfficial title:
Postoperative Recovery in Patients Undergoing Forefoot Bone Surgery. A Comparative Study of the Occurrence of a Rebound Pain Phenomenon According to the Use of Either a Popliteal Sciatic Nerve Block or a Distal Sensory Ankle Block
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).
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | March 1, 2024 |
Est. primary completion date | February 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
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. — View Citation
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. Erratum In: J Orthop Trauma. 2013 Mar;27(3):181. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | The investigators are interested in assessing the impact of sympathetic fibre block, thus the degree of local vasoplegia, on the incidence of the RP phenomenon. Sympathetic block (indirect indicator of modulation and increase of local inflammation) will be assessed by:
Repeated non-invasive measurement of local temperature changes (Digital infrared thermometer in the degree Celsius), Tissue oxygen perfusion by Periflux 6000 (oxygen values transcutaneous in millimeters of mercury ) and by the INVOS™ system, which monitors real-time changes in the percentage of regional oxygen saturation (rSO2) of blood in body tissues below the sensor. Measurement of inflammatory mediators by blood analysis, C-Réactive Proteine (CRP) value (in milligrams/liter) and NLR value (neutrophil to lymphocyte ratio). |
Through study completion, an average of 1 year | |
Secondary | Predictors of Pain Rebound in the Context of Forefoot Surgery with BNP | Preoperative questionnaires will be completed by the patients to identify possible predictive factors for the occurrence of RP and thus determine profiles more at risk. For this purpose, each patient will have to complete preoperatively :
A questionnaire assessing catastrophization which includes the evaluation of rumination , amplification , and helplessness (13 items scored from 0 to 4) A questionnaire assessing preoperative anesthetic and surgical anxiety APAIS (Amsterdam Preoperative Anxiety and Information Scale). The score can range from 6 ("no anxiety") to 30 ("very anxious"). A questionnaire evaluating the central sensitivity CSI (Central Sensitization Index) (9 questions) The DN4 (4 questions) and DN2 (2 questions) questionnaires which will allow to evaluate the risk of developing neuropathic pain . |
Through study completion, an average of 1 year |
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