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腘窝阻滞与踝关节阻滞下手术患者反跳痛发生的差异 (CBFR)

Rebound Pain Occurrence in Patients Undergoing Forefoot Bone Surgery Under Popliteal Sciatic Nerve Block or Distal Sensory Ankle Block: a Randomized Clinical Trial

This single-center, prospective, randomized controlled trial compared rebound pain (RP) occurrence following popliteal sciatic nerve block versus ankle block in patients undergoing elective forefoot bone surgery.

Patients were randomized to receive one of the two ultrasound-guided, single-injection peripheral nerve block techniques, combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion.

The primary objective was to compare RP incidence between the two block techniques. Secondary exploratory objectives included assessing postoperative pain trajectories and perioperative changes in skin temperature and tissue oxygen saturation as indirect indicators of local vasomotor and/or inflammatory responses.

Rebound pain was operationally defined as initially mild postoperative pain (NRS <4 at post-anesthesia care unit discharge), followed by severe pain (NRS ≥7) in the context of block resolution, typically described within 12-24 hours after block resolution. The exact interval between sensory recovery and severe pain onset was not systematically recorded.

研究概览

详细说明

This prospective, randomized, single-center controlled trial compared popliteal sciatic nerve block with ankle block in patients undergoing elective forefoot bone surgery. Participants were randomly allocated in a 1:1 ratio to either regional anesthetic technique, combined with standardized general anesthesia.

All peripheral nerve blocks were performed under ultrasound guidance before surgery using ropivacaine 0.5% with adrenaline (1:400,000) and clonidine (75 µg). Ankle blocks targeted the nerves supplying the surgical territory, while popliteal sciatic nerve blocks were supplemented by saphenous nerve blockade when required.

Before recruitment, the general anesthesia protocol was modified from the initially registered regimen involving sevoflurane maintenance to propofol target-controlled infusion for both induction and maintenance. This modification aimed to standardize anesthetic management and limit potential confounding effects on postoperative pain assessment. Sufentanil was reserved for intraoperative rescue analgesia but was not required. No intravenous ketamine, dexmedetomidine, or dexamethasone was administered.

Perioperative physiological assessments included infrared skin temperature measurements and tissue oxygen saturation monitoring using INVOS near-infrared spectroscopy on the operated and contralateral limbs. The originally planned Periflux measurements were discontinued before recruitment because the local heating required by this technique could interfere with skin temperature assessment. Preoperative hs-CRP and neutrophil-to-lymphocyte ratio measurements were performed, but the originally planned postoperative biomarker assessments were not conducted.

Postoperative analgesia was standardized using paracetamol and ibuprofen, with tramadol available as rescue medication. Patients remained hospitalized for approximately 24-48 hours, allowing clinical monitoring during sensory block regression and recovery. Follow-up assessments were conducted during hospitalization and by telephone on postoperative days 4 and 30 and at 3 months.

The study primarily compared rebound pain occurrence between the two regional anesthetic techniques. However, the exact onset of severe pain was not systematically timestamped, preventing reliable reconstruction of the originally registered 24-hour endpoint. The operational assessment and corresponding sensitivity analysis are specified in the Outcome Measures section.

研究类型

介入性

注册 (实际的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Brussels、比利时、1200
        • Cliniques universitaires Saint-Luc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Popliteal sciatic nerve block

An ultrasound-guided popliteal sciatic nerve block was performed using ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The popliteal block generally required 20-30 mL of local anesthetic solution. An additional ultrasound-guided saphenous nerve block was performed when indicated by the surgical territory, with total administered volumes reaching up to 40 mL. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg.

The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI).

Elective forefoot bone surgery under popliteal sciatic nerve

Elective forefoot bone surgery under an ankle block

其他:Ankle block

An ultrasound-guided ankle block was performed using 15-20 mL of ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The block targeted the saphenous, superficial peroneal, deep peroneal, and tibial nerves. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg.

The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI).

Elective forefoot bone surgery under popliteal sciatic nerve

Elective forefoot bone surgery under an ankle block

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of rebound pain following peripheral nerve block resolution
大体时间:During postoperative hospitalization (approximately 24-48 hours), including the period of sensory block resolution.

Rebound pain was assessed as severe postoperative pain (NRS ≥7) following initially mild pain (NRS <4) at post-anesthesia care unit discharge, in the context of peripheral nerve block resolution. Incidence was compared between popliteal sciatic nerve block and ankle block groups. A sensitivity analysis used the stricter NRS >7 threshold. The exact onset of severe pain was not systematically timestamped; therefore, the originally registered 24-hour endpoint could not be reliably reconstructed.

During postoperative hospitalization (approximately 24-48 hours), including the period of sensory block resolution.

次要结果测量

结果测量
措施说明
大体时间
Perioperative changes in skin temperature
大体时间:Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).

Skin temperature (°C) was measured using infrared thermometry on the operated and contralateral feet before and after peripheral nerve block, at emergence from general anesthesia, and on postoperative day 1. Changes over time and their association with rebound pain occurrence were explored.

Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Perioperative changes in tissue oxygen saturation
大体时间:Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).

Tissue oxygen saturation (%) was measured using near-infrared spectroscopy (INVOS) on the operated and contralateral feet before and after peripheral nerve block, at emergence from general anesthesia, and on postoperative day 1. Changes over time and their association with rebound pain occurrence were explored.

Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Preoperative Pain Catastrophizing Scale (PCS) score
大体时间:Preoperatively, before peripheral nerve block administration.

The Pain Catastrophizing Scale (PCS) was administered preoperatively to assess pain-related catastrophizing. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing. The PCS score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Preoperative Amsterdam Preoperative Anxiety and Information Scale (APAIS) score
大体时间:Preoperatively, before peripheral nerve block administration.

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was administered preoperatively to assess anxiety and information needs related to anesthesia and surgery. The total APAIS score ranges from 6 to 30, with higher scores indicating greater preoperative anxiety and/or information needs. The total score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Preoperative Central Sensitization Inventory (CSI-9) score
大体时间:Preoperatively, before peripheral nerve block administration.

The nine-item Central Sensitization Inventory (CSI-9) was administered preoperatively to assess symptoms associated with central sensitization. The total score ranges from 0 to 36, with higher scores indicating a greater burden of symptoms associated with central sensitization. The CSI-9 score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Preoperative DN4 questionnaire score
大体时间:Preoperatively, before peripheral nerve block administration.

The Douleur Neuropathique en 4 Questions (DN4) questionnaire was administered preoperatively to assess neuropathic pain characteristics. The total score ranges from 0 to 10, with higher scores indicating more neuropathic pain features. A score of 4 or higher suggests a neuropathic pain component. The DN4 score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.

Preoperatively, before peripheral nerve block administration.
Postoperative DN2 score at day 4
大体时间:Postoperative day 4.

The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered on postoperative day 4 to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.

Postoperative day 4.
Postoperative DN2 score at day 30
大体时间:Postoperative day 30.

The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered on postoperative day 30 to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.

Postoperative day 30.
Postoperative DN2 score at 3 months
大体时间:3 months after surgery.

The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered three months after surgery to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.

3 months after surgery.
Preoperative high-sensitivity C-reactive protein (hs-CRP) level
大体时间:Preoperatively, before surgery.

High-sensitivity C-reactive protein (hs-CRP) levels were measured preoperatively (mg/L) as an exploratory marker of baseline systemic inflammation. Values were descriptively compared between the popliteal sciatic nerve block and ankle block groups. Postoperative hs-CRP measurements originally planned in the study protocol were not performed.

Preoperatively, before surgery.
Preoperative neutrophil-to-lymphocyte ratio (NLR)
大体时间:Preoperatively, before surgery.

The neutrophil-to-lymphocyte ratio (NLR) was calculated from preoperative blood cell counts as an exploratory marker of baseline systemic inflammation. This dimensionless ratio was descriptively compared between the popliteal sciatic nerve block and ankle block groups. Postoperative NLR measurements originally planned in the study protocol were not performed.

Preoperatively, before surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nassim TOUIL, MD、Cliniques universitaires Saint-Luc- Université Catholique de Louvain

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年4月24日

初级完成 (实际的)

2025年7月7日

研究完成 (实际的)

2025年7月7日

研究注册日期

首次提交

2023年1月17日

首先提交符合 QC 标准的

2023年2月15日

首次发布 (实际的)

2023年2月21日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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