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Compare Continuous Gastrocnemius Plane Block With Intravenous Analgesia After Foot and Ankle Surgery

Primary Purpose

Foot Ankle Injuries

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Continuous Gastrocnemius plane block with ropivacaine
oxycodone
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ankle Injuries focused on measuring nerve block, Continuous Gastrocnemius plane block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective foot and ankle surgery
  • Patient informed consent was obtained
  • Age 18 to 65 years Sex is not limited
  • American Society of Anesthesiologists(ASA)Ⅰ~Ⅲ level
  • Body Mass Index(BMI)18~28kg/m2

Exclusion Criteria:

  • Puncture site infection
  • Abnormal coagulation function
  • Local anesthetic allergy
  • Severe cardiopulmonary disease
  • Liver and renal insufficiency
  • Medical history of chronic pain
  • Long-term use of sedative and analgesic drugs
  • Communication disorders
  • The operation time exceeded 3 hours

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Experimental group: Ropivacaine-controlled analgesia pump

    Control group: oxycodone-controlled analgesia pump

    Arm Description

    A single injection of 0.375% Ropivacaine 15 milliliters was given into the common peroneal nerve, medial sural cutaneous nerve, and lateral sural cutaneous nerve. Than,a catheter was placed in the gastrocnemius plane, and a 0.125% ropivacaine-controlled analgesic pump was applied.(The formulation was 0.125% ropivacaine at 300 milliliters, with a background dose of 3 milliliters/hours, a patient-controlled analgesia(PCA) dose of 8 milliliters, and a locking time of 25 minutes.)

    No treatment was given preoperatively, and postoperative oxycodone patient-controlled intravenous analgesia(PCIA). After awakening, intravenous oxycodone was titrated according to numerical rating scale(NRS) score, providing analgesia without background dose of oxycodone patient-controlled intravenous analgesia(PCIA) pump (single dose 1 milligram, locking time 5 minutes, 14 hours limit 12 milligrams)

    Outcomes

    Primary Outcome Measures

    Area under the pain intensity-time curve
    The smaller the area under the pain intensity-time curve, the better the nerve block effect

    Secondary Outcome Measures

    Percentage of subjects without remedial analgesics
    The greater the percentage of subjects without remedial analgesics, the better the nerve block
    The cumulative amount of remedial analgesic drugs (oxycodone) used
    The smaller the cumulative amount of remedial analgesic drugs, the better the nerve blockade
    Number of remedial analgesia
    The less the remedial analgesia is, the better the nerve blockade is
    Number of effective patient controlled analgesia (PCA) compressions
    Number of effective patient controlled analgesia (PCA) compressions
    The proportion of the number of invalid presses to the total presses
    A smaller proportion of ineffective presses to total presses indicates a better nerve block
    Total number of patient controlled analgesia (PCA) presses
    Total number of patient controlled analgesia (PCA) presses

    Full Information

    First Posted
    July 4, 2022
    Last Updated
    July 14, 2022
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05463809
    Brief Title
    Compare Continuous Gastrocnemius Plane Block With Intravenous Analgesia After Foot and Ankle Surgery
    Official Title
    A Randomized Controlled Trial of Continuous Gastrocnemius Plane Block and Intravenous Analgesia After Foot and Ankle Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 14, 2022 (Anticipated)
    Primary Completion Date
    January 30, 2023 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing First Hospital, Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the efficacy and safety of a continuous gastrocnemius plane block for perioperative analgesia in patients undergoing foot and ankle surgery under elective general anesthesia.
    Detailed Description
    Anatomical studies show that the 0.2% methylene blue was injected into the upper and lower surface of the gastrocnemius muscle and then diffused to the periphery.The common peroneal nerve, the medial sural cutaneous nerve, the lateral sural cutaneous nerve and the tibial nerve below the gastrocnemius muscle are all strongly stained (3 / 4 color of the nerve) or fully stained. Previous clinical studies have shown that a single gastrocnemius muscle plane block can provide good postoperative analgesia after 16 hours for patients with foot and ankle surgery, significantly reduce the dose of opioids, and see no nerve injury. Therefore, the investigators hypothesized that continuous gastrocnemius plane block could provide more lasting analgesia in patients undergoing foot-ankle surgery. This clinical study uses a single-center, randomized, single-blind, parallel controlled trial design, divided into screening period, treatment period and follow-up periods. Patients were randomized into two groups, the ropivacaine group and the control group.The venous access was open after home invasion and was routinely monitored electrocardiogram(ECG), non-invasive blood pressure(NBP) ,oxygen saturation(SpO2),bispectral index(BIS). General anesthesia was performed. Induction of anesthesia: propofol 1 milligram / kg, cis atracurium 0.2 milligrams / kilogram, sufentanil 10 micrograms ,remifentanil at 1.5 micrograms/ kilogram. Anesthesia maintenance: Propofol and sevoflurane static aspiration compound bispectral index was maintained at 40~60, remifentanil 0.3~0.4 μg / kg/min intravenous pump, and additional cis atracurium was added according to neuromuscular monitoring. In the postoperative ropivacaine group, the patient took a lateral decubitus position, and underwent a gastrocnemius plane block and catheterization under ultrasound guidance to connect a disposable electron infusion pump. (Formula of 0.125% ropivacaine of 300 milliliters, background dose of 3.0 milliliters / hour, patient controlled analgesia(PCA) dose of 8 milliliters , and locking time of 25 minutes). The control group received intravenous oxycodone titrated according to the numerical rating scale (NRS) score, and received no background dose of oxycodone patient-controlled intravenous analgesia (PCIA) pump for analgesia (single dose 1milligram, locking time 5minutes, 4 hours limit 12milligrams). All patients were given 50 milligrams of fluorophenol ester intravenously. Remedial analgesia: if patient controlled analgesia still can not tolerate the pain and numerical rating scale(NRS) ≥4, can be given intravenously oxycodone was done 2milligrams, separated by over 3 minutes, until numerical rating scale(NRS) ≤3. Record: block range of 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, 48hours and numerical rating scale(NRS) score during rest and exercise; time of first pressing of the analgesic pump; times of controlled analgesia (PCA); 0-4 hours, 0-8 hours, 0-16 hours, 0-24 hours, 8-16 hours, 16-24 hours, 24-32 hours, 32-40 hours,40-48 hours pain intensity-time curve (AUC); dose and times of remedial analgesic administration; Records: affected limb muscle strength and paresthesia, length of hospitalization, time of first ambulation, nausea and vomiting, neurological complications, patient satisfaction, physician and nurse satisfaction, etc. The patient had open venous access after home invasion and was routinely monitored for electrocardiogram(ECG), non-invasive blood pressure(NBP) ,oxygen saturation(SpO2) and bispectral index(BIS). Induction and maintenance were performed according to a uniform anesthesia protocol. Postoperatively, the block was performed by the same anesthesiologist familiar with the ultrasound-guided nerve block. Various study indicators and data were collected by the same anesthesiologist who was not aware of the grouping situation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Foot Ankle Injuries
    Keywords
    nerve block, Continuous Gastrocnemius plane block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group: Ropivacaine-controlled analgesia pump
    Arm Type
    Experimental
    Arm Description
    A single injection of 0.375% Ropivacaine 15 milliliters was given into the common peroneal nerve, medial sural cutaneous nerve, and lateral sural cutaneous nerve. Than,a catheter was placed in the gastrocnemius plane, and a 0.125% ropivacaine-controlled analgesic pump was applied.(The formulation was 0.125% ropivacaine at 300 milliliters, with a background dose of 3 milliliters/hours, a patient-controlled analgesia(PCA) dose of 8 milliliters, and a locking time of 25 minutes.)
    Arm Title
    Control group: oxycodone-controlled analgesia pump
    Arm Type
    Experimental
    Arm Description
    No treatment was given preoperatively, and postoperative oxycodone patient-controlled intravenous analgesia(PCIA). After awakening, intravenous oxycodone was titrated according to numerical rating scale(NRS) score, providing analgesia without background dose of oxycodone patient-controlled intravenous analgesia(PCIA) pump (single dose 1 milligram, locking time 5 minutes, 14 hours limit 12 milligrams)
    Intervention Type
    Drug
    Intervention Name(s)
    Continuous Gastrocnemius plane block with ropivacaine
    Other Intervention Name(s)
    Automatic analgesic pump
    Intervention Description
    After extubation, the patient was routinely monitored for his vital signs.The nerve block operation was performed by the same doctor: let the patient take the lateral decubitus position, use the ultrasonic high-frequency array probe under the popliteal socket to scan the sciatic nerve, move the probe down to find the tibial nerve and the common peroneal nerve, and then a single injection of 0.375% Ropivacaine 15milliliters was given into the common peroneal nerve, medial sural cutaneous nerve, and lateral sural cutaneous nerve. Then avoid common peroneal nerve, use the indwelling needle (16GA 3.25 IN), and put the catheter after saline expansion.
    Intervention Type
    Drug
    Intervention Name(s)
    oxycodone
    Other Intervention Name(s)
    Automatic analgesic pump
    Intervention Description
    The patient was revived and received intravenous oxycodone titration according to the numerical rating scale (NRS) score, and was treated with no background dose of oxycodone patient-controlled intravenous analgesia (PCIA) pump for analgesia.
    Primary Outcome Measure Information:
    Title
    Area under the pain intensity-time curve
    Description
    The smaller the area under the pain intensity-time curve, the better the nerve block effect
    Time Frame
    Up to 48 hours postoperative
    Secondary Outcome Measure Information:
    Title
    Percentage of subjects without remedial analgesics
    Description
    The greater the percentage of subjects without remedial analgesics, the better the nerve block
    Time Frame
    Up to 48 hours postoperative
    Title
    The cumulative amount of remedial analgesic drugs (oxycodone) used
    Description
    The smaller the cumulative amount of remedial analgesic drugs, the better the nerve blockade
    Time Frame
    Up to 48 hours postoperative
    Title
    Number of remedial analgesia
    Description
    The less the remedial analgesia is, the better the nerve blockade is
    Time Frame
    Up to 48 hours postoperative
    Title
    Number of effective patient controlled analgesia (PCA) compressions
    Description
    Number of effective patient controlled analgesia (PCA) compressions
    Time Frame
    Up to 48 hours postoperative
    Title
    The proportion of the number of invalid presses to the total presses
    Description
    A smaller proportion of ineffective presses to total presses indicates a better nerve block
    Time Frame
    Up to 48 hours postoperative
    Title
    Total number of patient controlled analgesia (PCA) presses
    Description
    Total number of patient controlled analgesia (PCA) presses
    Time Frame
    Up to 48 hours postoperative
    Other Pre-specified Outcome Measures:
    Title
    The incidence of muscle strength and sensory abnormalities in the affected limb
    Description
    The lower the incidence of muscle strength and sensory abnormalities in the affected limb, the better the effect of continuous gastrocnemius plane block
    Time Frame
    Up to 48 hours postoperative
    Title
    The incidence of adverse reactions, such as nausea, vomiting, and neurological complications
    Description
    The lower the incidence of adverse effects such as nausea, vomiting, and neurological complications, the better the continuous gastrocnemius plane block technique
    Time Frame
    Up to 48 hours postoperative
    Title
    First time to get out of bed
    Description
    First bedtime helps to judge the effect of the nerve block
    Time Frame
    Up to 48 hours postoperative
    Title
    The incidence of adverse events
    Description
    Prevent adverse events such as catheter leakage and shedding
    Time Frame
    Up to 48 hours postoperative
    Title
    Patient satisfaction score
    Description
    Rated on a 0-10 scale, with a higher score representing greater satisfaction.
    Time Frame
    Up to 48 hours postoperative
    Title
    The incidence of outbreak pain
    Description
    Patients with a single nerve block will have a burst of pain phenomenon, so we need to record the presence of a postoperative burst of pain phenomenon in patients with consecutive blocks
    Time Frame
    Up to 7 days postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing elective foot and ankle surgery Patient informed consent was obtained Age 18 to 65 years Sex is not limited American Society of Anesthesiologists(ASA)Ⅰ~Ⅲ level Body Mass Index(BMI)18~28kg/m2 Exclusion Criteria: Puncture site infection Abnormal coagulation function Local anesthetic allergy Severe cardiopulmonary disease Liver and renal insufficiency Medical history of chronic pain Long-term use of sedative and analgesic drugs Communication disorders The operation time exceeded 3 hours
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jie Wei
    Phone
    18752113232
    Email
    961683175@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liu Han
    Phone
    18951670163
    Email
    han_cold.student@sina.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12043982
    Citation
    Provenzano DA, Viscusi ER, Adams SB Jr, Kerner MB, Torjman MC, Abidi NA. Safety and efficacy of the popliteal fossa nerve block when utilized for foot and ankle surgery. Foot Ankle Int. 2002 May;23(5):394-9. doi: 10.1177/107110070202300504.
    Results Reference
    background
    Citation
    Sun Li, Wei Jinju. Patient VAS was scored by ultrasound-guided continuous sciatic nerve block during foot surgery And the effect analysis of morphine dosage. Journal of Mathematical Medicine, 2019,32 (4): 523-524.
    Results Reference
    background
    PubMed Identifier
    26109605
    Citation
    Anderson JG, Bohay DR, Maskill JD, Gadkari KP, Hearty TM, Braaksma W, Padley MA, Weaver KT. Complications After Popliteal Block for Foot and Ankle Surgery. Foot Ankle Int. 2015 Oct;36(10):1138-43. doi: 10.1177/1071100715589741. Epub 2015 Jun 24.
    Results Reference
    background
    Citation
    Zhang Jinfang, Li Yimei. Ultrasound-guided continuous popliteal sciatic nerve block for postoperative analgesia in patients undergoing foot and ankle surgery. The World's Latest Medical Information Abstract, 2019,19 (68): 1-3.
    Results Reference
    background
    Citation
    Qiu Wen, Yu Bin. Randomized controlled study of continuous popliteal sciatic nerve block analgesia and intravenous analgesia after foot and ankle surgery. Journal of Tongji University (Medical edition), 2 018,39 (02): 99-102.
    Results Reference
    background
    PubMed Identifier
    22735198
    Citation
    Gartke K, Portner O, Taljaard M. Neuropathic symptoms following continuous popliteal block after foot and ankle surgery. Foot Ankle Int. 2012 Apr;33(4):267-74. doi: 10.3113/FAI.2012.0267.
    Results Reference
    background
    Citation
    Bai Shu order, should be dajun et al. descriptive anatomy. The People's Health Publishing House. 353-357.
    Results Reference
    background
    Citation
    Dong Guangyu, Huang Bingzhe, Zhang Hanyang, Chang Fei. Ankle joint block treatment. The Electronic Journal of Foot and Ankle Surgery. 2017, 4(3):59.
    Results Reference
    background

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