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Foot Ankle InjuriesPhase 3NCT05463809

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

A Phase 3 study testing Continuous Gastrocnemius plane block with ropivacaine and oxycodone in people with Foot Ankle Injuries, run by Nanjing First Hospital, Nanjing Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Foot Ankle Injuries
What is being tested?
Continuous Gastrocnemius plane block with ropivacaine and oxycodone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
14 Jul 2022to 1 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Puncture site infection
  • Abnormal coagulation function
  • Local anesthetic allergy
  • Severe cardiopulmonary disease
  • Liver and renal insufficiency
  • Medical history of chronic pain
Show all 9Show fewer
  • Long-term use of sedative and analgesic drugs
  • Communication disorders
  • The operation time exceeded 3 hours

Trial locations and contacts

No sites are listed yet.

About this study

Official title: A Randomized Controlled Trial of Continuous Gastrocnemius Plane Block and Intravenous Analgesia After Foot and Ankle Surgery

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.

Read the 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.

Being tested
Continuous Gastrocnemius plane block with ropivacaine, oxycodone
Keywords
nerve block, Continuous Gastrocnemius plane block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Gastrocnemius plane block with ropivacaineDrug

    Also called Automatic analgesic pump

    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.

  • oxycodoneDrug

    Also called Automatic analgesic pump

    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.

Study groups in NCT05463809
Study groupRoleWhat they receive
Experimental group: Ropivacaine-controlled analgesia pumpExperimentalA 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.)
Receives: Drug: Continuous Gastrocnemius plane block with ropivacaine
Control group: oxycodone-controlled analgesia pumpExperimentalNo 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)
Receives: Drug: oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the pain intensity-time curve

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

    Measured: Up to 48 hours postoperative

Secondary outcomes (6)
  1. Percentage of subjects without remedial analgesics

    The greater the percentage of subjects without remedial analgesics, the better the nerve block

    Measured: Up to 48 hours postoperative

  2. The cumulative amount of remedial analgesic drugs (oxycodone) used

    The smaller the cumulative amount of remedial analgesic drugs, the better the nerve blockade

    Measured: Up to 48 hours postoperative

  3. Number of remedial analgesia

    The less the remedial analgesia is, the better the nerve blockade is

    Measured: Up to 48 hours postoperative

  4. Number of effective patient controlled analgesia (PCA) compressions

    Number of effective patient controlled analgesia (PCA) compressions

    Measured: Up to 48 hours postoperative

  5. 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

    Measured: Up to 48 hours postoperative

  6. Total number of patient controlled analgesia (PCA) presses

    Total number of patient controlled analgesia (PCA) presses

    Measured: Up to 48 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start14 Jul 2022 (estimated)
  3. Primary completion30 Jan 2023 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463809
Sponsor's protocol ID
Han Liu
Status last verified
Jun 2022
First submitted
4 Jul 2022
Last updated
19 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12043982
  • 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.

  • 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.

    PubMed 26109605
  • 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.

  • 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.

  • 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.

    PubMed 22735198
  • Bai Shu order, should be dajun et al. descriptive anatomy. The People's Health Publishing House. 353-357.

  • Dong Guangyu, Huang Bingzhe, Zhang Hanyang, Chang Fei. Ankle joint block treatment. The Electronic Journal of Foot and Ankle Surgery. 2017, 4(3):59.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Continuous Gastrocnemius plane block with ropivacaine and oxycodone in people with Foot Ankle Injuries, run by Nanjing First Hospital, Nanjing Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jie Wei (18752113232, 961683175@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the pain intensity-time curve (time frame: Up to 48 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463809, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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