A Randomized Controlled Trial of Continuous Gastrocnemius Plane Block and Intravenous Analgesia After Foot and Ankle Surgery
Phase: PHASE3
Conditions: Foot Ankle Injuries
Sponsor: Nanjing First Hospital, Nanjing Medical University

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PROTOCOL
The research program of ultrasound-guided continuous gastrocnemius plane block
July 14, 2022

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The research program of ultrasound-guided continuous gastrocnemius plane
block
1 Research background Foot and ankle surgery is a common kind of clinical surgery,
mainly including ankle fracture internal fixation, bunion valgus correction and ankle
skin debridement.It has been shown that foot and ankle surgery can cause moderate to
severe severe pain, often producing long-term postoperative pain[1]. Often need large
doses of analgesics to auxiliary treatment, intravenous although analgesia can achieve
certain analgesic effect, but easy to cause adverse reactions such as vomiting, nausea,
has certain limitations, ultrasound guide peripheral nerve block is a kind of analgesic
method in recent years, has been the height of clinical staff recognized [2].
The nerve block commonly used for foot and ankle surgery is the sciatic nerve block
at the popliteal level.Sciatic nerve block is widely used for postoperative analgesia in
patients, but not without complications.A retrospective analysis of 1014 patients
undergoing foot or ankle surgery for popliteal sciatic nerve block identified 5% with
associated neuropathy and 0.7% with sciatic neuropathy symptoms still not resolved
at the last follow-up for the suspected[3] with nerve block. The continuous sciatic
nerve block catheterization technique is relatively complex, with not only the risk of
catheter prolapse and leakage of[4,5], but also the risk of nerve injury. One prospective
study reported 147 popliteal tube patients at 2 weeks in 41%, down to 24% at 34
weeks, and 3.4% of these patients had severe symptoms, probably also a nerve
block-induced nerve [6].
The sensation of the foot and ankle joints is provided by the branches of the sciatic
and femoral nerves: 1. The end of the femoral nerve is the cryptic nerve that provides
sensation to the medial side of the foot. 2.The common peroneal nerve is divided into
the superficial sural nerve, which provides sensation for the dorsal foot and 2-5 toes;
the deep sural nerve provides sensory [3,7] for the opposite edge of 1-2 toes. 3.The
sciatic nerve is divided into the tibial nerve and The common peroneal nerve .The
tibial nerve provides plantar sensation through the medial plantar, lateral and calcanus
nerves. 4.The sural nerve usually comes from the branches of the common peroneal
nerve and the tibial nerve, and provides the lateral side of the foot, the dorsum of the
foot and the lateral edge of the small toe feel like the [4,8].
Dissection revealed the common peroneal nerve beyond the lateral head of the
gastrocnemius muscle, located in the depression between the biceps tendon and the
lateral margin of the gastrocnemius tendon. The common peroneal nerve runs behind
the small fibular head and around the fibular neck forward through the long peroneal
muscle and is divided into shallow, peroneal and deep nerves. The tibial nerve is
accompanied by the popliteal vessel in the popliteal fossa, passes through the deep
surface of the soleus muscle with a descending posterior tibial artery, bypassing the
medial malleolus, and is divided into plantar olateral and medial plantar nerves.The
gastroemal nerve drops between the gastrocnemius muscles and is superficial on the
far side of the calf. The common peroneal nerve
crosses the back of the lateral head
of the gastrocnemius muscle (in the depression between the biceps tendon and the
lateral margin of the peremius tendon), behind the small head of the fibular bone and

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around the neck of the perfibular muscle into the superficial sural and deep
nerves.The tibial nerve is accompanied by popliteal vessels in the popliteal fossa,
walking in the gastrocnemius muscle, and penetrates the gastrocnemius in the middle
and upper calf into the deep surface of the soleus muscle with posterior tibial artery
decline. The peroneal nerve drops along between the gastrocnemius muscles and is
superficial to the subcutaneous [7] in the calf. Therefore, the local anesthetic given on
the surface of the gastrocnemius muscle can theoretically block the common peroneal
nerve, and between the gastrocnemius muscle and the soleus muscle, it can block the
tibial nerve. Muscular space administration can avoid nerve injury, reduce the
operation difficulty of sciatic nerve block, and facilitate the catheterization and
analgesia of continuous common peroneal nerve and tibial nerve block.
Directory of references
1、A. Provenzano, M.D; Eugene R.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.
2、Sun Li, Wei Jinju. Patient VAS was scored by ultrasound-guided continuous sciatic
nerve block during foot surgery
And the impact analysis of the amount of morphine used. Journal of Mathematical
Medicine, 2019,32 (4): 523-524.
3、Anderson JG, Bohay DR, Maskill JD, et al. Complications after popliteal block for
foot and ankle surgery. Foot Ankle Int 2015;36(10):1138–43.
4、Zhang Jinfang, Li Yimei. Ultrasound-guided continuous popliteal sciatic nerve
block for postoperative analgesia in patients undergoing foot and ankle surgery.
5、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.
6 、Kathleen Gartke, MD, FRCSC; Oliver Portner,etal.Neuropathic Symptoms
Following Continuous Popliteal Block After Foot and Ankle Surgery.Foot Ankle Int.
2012 Apr;33(4):267-74.
7、Bai Shu order, should be dajun et al. descriptive anatomy. The People's Health
Publishing House. 353-357.
8、Dong Guangyu, Huang Bingzhe, Zhang Hanyang, Chang Fei. Ankle joint block
treatment. The Electronic Journal of Foot and Ankle Surgery. 2017,
4(3):59.
2 Study objective and study endpoint
Efficacy and safety study of ultrasound-guided gastrocnemius plane catheterization
for analgesia after foot and ankle surgery-single Central, randomized, single-blind,
parallel-controlled study.
2.1 Study Purpose
2.1.1 Main study objective: To evaluate the gastrocnemius plane catheterization for
patients with foot and ankle surgery under elective general anesthesia efficacy of
analgesia during the operative period.
2.1.2 Secondary
study objective: To evaluate
the plane
tube emulation
of
gastrocnemius muscle for patients with foot and ankle surgery under elective general

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anesthesia safety of analgesia during surgery.
2.2 Study endpoint
2.2.1 Primary study endpoints
PI-AUC48 (the area under the pain intensity-time curve within 48h after the first start
of the postoperative administration)
2.2.2 Secondary study endpoints
2.2.2.1 Effectiveness study endpoint
1) Accumulated amount of remedial analgesic drugs (oxycodone, calculated as mg)
used within 0-48h after the first start of postoperative drug administration;
2) Percentage of subjects who did not use remedial analgesics within 0-48h after the
first start of postoperative administration;
3) Number of remedial analgesia within 0-48h after the first start of postoperative
drug administration;
4) Total number of PCA compressions within 0-48h after the first start of
postoperative drug administration;
5) Number of effective PCA compressions within 0-48h after the first start of
postoperative drug administration;
6) Subject satisfaction score at 48h after the first start of postoperative drug
administration;
2.2.2.2. Safety study endpoint
1) The incidence and severity of various adverse events (AE) from the first start of
drug administration to the end of the trial;
2) The incidence and severity of adverse events of nausea and vomiting from the first
start of drug administration to the end of the trial;
3) The incidence and severity of muscle strength and paresthesia in the affected limb
from the first drug administration until the end of the trial;
3. Expected results
Ultrasound-guided gastrocnemius muscle plane catheterization can be effective and
safe for analgesia after foot and ankle surgery.
4. Design and method of the study
This clinical study uses a single-center, randomized, single-blind, parallel controlled
trial design, divided into screening period, treatment period and follow-up periods.
4.1.1 Screening period:
Patients undergoing elective foot and ankle surgery gave informed consent to be
enrolled, and subjects who met all enrollment criteria and did not meet any exclusion
criteria were obtained a randomization number and drug number 1 day before the
surgery or the day of the surgery in a 1:1 ratio to the trial and placebo control groups.
4.1.2 Treatment Period
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
ECG，NBp，SpO₂，BIS。General anesthesia was performed.
Induction of anesthesia: propofol 1mg / kg, cis atracuronium 0.2mg / kg, sufentanil
10ug, remie Tanyl at 1.5 g / kg. Anesthesia maintenance: Propofol and sevoflurane
static aspiration compound BIS was maintained at 40~60, remifentanil 0.3~0.4 g /

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kg/min intravenous pump, and additional cis atracurium was added according to
myasasone 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 300mL, background dose of 3.0 mL/h,
PCA dose of 8 ml, and locking time of 25min). The control group received
intravenous oxycodone titrated according to the NRS score, and received no
background dose of oxycodone PCIA pump for analgesia (single dose 1mg, locking
time 5min, 4h limit 12mg). All patients were given 50mg of fluoroprirol ester
intravenously.
Remedial analgesia: if PCA analgesia still can not tolerate the pain and NRS ≥4, can
be given intravenously oxycodone was done 2mg, separated by over 3 min, until NRS
≤3.
4.1.3 Follow-up period
Record: block range of 15min, 30min, 45min, 60min, 90min, 1h, 4h, 8h, 12h, 24h,
48h and NRS score during rest and exercise; time of first pressing of the analgesic
pump; times of controlled analgesia (PCA); 0-4h, 0-8h, 0-16h, 0-24h, 8-16h, 16-24h,
32h, 32-40h 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.
5.0 Study the implementation process
The patient had open venous access after home invasion and was routinely monitored
for ECG, NBP, SpO2, and 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.

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6. Subject recruitment and protective measures
6.1 Inclusion criteria
Patients undergoing elective foot and ankle surgery; the patient gave informed consent;
age 18~65y and gender; ASAⅠ~Ⅲ; BMI 18 ~ 28 kg/m².
6.2 Exclusion criteria
puncture site infection, abnormal coagulation function, local anesthetic allergy, severe
cardiopulmonary disease, liver and renal insufficiency, long-term use of sedative and
analgesic drugs, communication disorders, history of chronic pain, and operation time
exceeded 3h.
6.3 Exit criteria
Patients may withdraw their informed consent and withdraw from the trial at any
time.
The investigator may decide on the subject to terminate the withdrawal from the study
in the following circumstances.
1) Any medical condition occurring in the study may lead to the risk of continuing the
study subjects;
2) The subject receives analgesic treatment other than the prescribed analgesic remedy
protocol, and other subjects who cannot complete the test according to the provisions
of the test protocol;
3) The researcher judges other situations that should withdraw from the trial.
7 Informed consent
7.1 The Informed Consent Form
The informed consent was in accordance with the ethical principles outlined in the
Declaration of Helsinki.The informed consent form detailed the study protocol and
process, and fully explained the risks of the study.

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The informed consent form also states that the records of the individual identity must
be kept confidential, but the research team and regulators can access the subject
information.
7.2 Informed consent process and recording
Informed consent begins before the individual consent to participate in clinical studies
and continued throughout the course of the clinical study.
7.3 Confidential
Personal patient information will be given as confidential information.All patient data
obtained from the patient cases will be kept as confidential.Patients will be identified
by
their
name
acronym
and
the
numbers
provided
at
the
time
of
study
inclusion.Patients or their families will be aware of the anonymity of the data and
their right to protect their privacy.However, it is also important to understand the fact
that the data will be submitted to the subject responsible unit or the government
management authority, and may also be submitted to institutions such as the Ministry
of Health for inspection and evaluation.The participating physician will keep a list of
patient personal data (patient data and corresponding patient names) for confirmation
of the record.
8. Quality control and quality assurance
8.1 Qualification of research unit and researcher qualification
The research unit shall have the experience in drug research, the facilities and
conditions of the department where the project belongs shall meet the needs of safe
and effective clinical research, and the researchers shall have the professional
expertise, qualifications and ability to undertake the clinical research, and shall be
trained in GCP regulations.
9.2 Training of the researchers
Before the start of the study, the research leaders of each center should organize the
researchers to study the program, and only the researchers who have passed the
program training can participate in the study to ensure that the researchers have a
consistent understanding of the protocol.For important assessment scales, relevant
personnel in the participating centers need systematic training and even obtain
corresponding qualification certificates.
8.3 Surveillance of clinical trials
A hospital ethics committee and institutional review board may conduct a systematic
review of the clinical trial-related activities and documents, to evaluate whether the
trial was conducted in accordance with the trial protocol, SOP, and relevant
regulations, and whether the trial data are timely, true, accurate, and complete
records.The audit should be performed by those who do not directly involve the
clinical trial.
9. Organization and management of the research
9.1 Change of the scheme
All additional or referenced appendices are integral parts of the scheme.No one shall
make any modifications or revisions to any part of the research protocol, as signed by
the investigator and the principal of the project, unless these changes or revisions have
been fully discussed.And through the unanimous consent of the researcher and the

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subject leader.Any agreed modification will be recorded and will be signed by the
investigator and the project leader
The case is filed together.
9.2 Retention of the records
The investigator shall keep all the detailed original documents of the subject, and
record the trial process, medication status, laboratory examination data, safety data
and efficacy assessment in the case report form. The recorded data shall be complete,
timely and clear.The original documents and medical records should be clear, detailed
and easily identified by those participating in this clinical trial.
The case report form and the original files can only be modified by the
investigator.No modification to the case report form and the original file shall smear
the original data off.The correct way to modify is to line the original data, and then
write the modified data next to the original data, and sign the date and the name of the
modification.Test data shall be retained until 5 years after the termination of the test.
9.3 Early termination of the study
The leader of the project decides to stop or interrupt the study in advance in the case
of force majeure, and should inform the doctors involved in the study in
writing.Similarly, any participating unit that decides to withdraw from the study for
any reason should also notify the project leader in written form.
9.4 Research, supervision and inspection
9.4.1 Research supervision
Inspectors must follow the drug clinical trial quality management specification (GCP)
and standard operation procedures (SOP), visit the research unit regularly or
according to the actual situation, supervise the clinical trial work and progress, check,
confirm all data records and reports, correct and complete, consistent with the original
data, ensure the clinical trial in accordance with the clinical trial protocol, the
researchers should actively cooperate with the inspectors.The specific contents of the
inspector include:
A) Ensure before the test that the test undertaking unit has appropriate conditions,
including staffing and training, complete laboratory equipment and good operation,
various inspection conditions related to the test, and estimated sufficient quantity
All the participants were familiar with the requirements in the test protocol;
? b) Monitor the implementation of the trial protocol during the trial, confirm that the
informed consent of all subjects is obtained before the trial, understand the enrollment
rate of the subjects and the progress of the trial, and confirm that the selected subjects
are qualified;
c) Confirm that the records and reports of all data are correct and complete, and that
all case report forms are entered correctly and consistent with the original data.All
errors or omissions have been corrected or indicated, signed and dated by the
Investigator.
d) Verify that all adverse events are recorded, and that serious adverse events shall be
reported and recorded within the specified time;
e) Clearly and truthfully record the failed visits, unconducted tests, and undone checks
should be made, and whether the errors and omissions should be corrected;

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f) The written inspection report shall be completed after each visit, which shall state
the date, time, name of the inspector, findings of the inspection, etc.
9.4.2 On-site inspection
The responsible unit may conduct an on-site inspection of the research at a clinical
research institution.The audit includes the required test documents, records of the
informed consent process, and the consistency of the eCRF and the original
documents.But also the content and scope of the inspection can be increased
according to the situation.The investigator agrees to participate at a reasonable time
and in a reasonable manner.
11. Investigators' responsibilities
10.1 Participating physician responsibilities
The participating physicians will implement the study following the study protocol
and confirm the accuracy of the data entered.The participating physicians should be
responsible for obtaining written signed informed consent for data collection from the
study subjects.
10.2 Responsibility of the project leader
The project leader takes all reasonable steps and provides sufficient resources to
ensure the implementation of the research, mainly involving the following aspects:
A) Ensure that the study complies with relevant national and local regulations,
including ethical requirements, patient data protection regulations, etc.
b) Ensure the effectiveness of quality control and analysis of research results.
11. Results sharing
The intellectual property rights, trial data and research results related to this
anatomical study are jointly owned by the Nanjing First Hospital and the Department
of Anesthesiology, and the University and the Anatomy Teaching and Research
Section of Nanjing Medical University.
The intellectual property rights, trial data and research results related to this clinical
study are owned by Nanjing First Hospital and the Department of Anesthesiology.
12. Data analysis
Data collection: It was collected by the same anesthesiologist who did not know the
grouping situation.
Data were calculated using SPSS 22.0 statistical software.Normally distributed
measurement data are expressed as mean ± standard deviation (x ± s), using one-way
ANOVA and using χ2 test, P <0.05 was significant.
13. Ethics principles and requirements for clinical research
Clinical research will follow the world medical congress of the declaration of Helsinki
and the national health and family planning commission of the People's Republic of
China involving human biomedical research ethics review method and other relevant
provisions, the specific implementation of informed consent, the privacy protection,
research free and compensation, risk control, special subject protection and research
related damage compensation principles and requirements.The clinical study was
performed before the ethics committee approved the trial protocol.Before each subject
is enrolled in the study, the investigator has the responsibility to present the subject or
his legal agent about the purpose, procedures of the study and possible risks, and sign

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a written informed consent form that their participation in the clinical study is
completely voluntary, that they may refuse to participate or withdraw from the study
at any time at any stage of the trial without discrimination and retaliation, and their
medical treatment and interests are not affected.The informed consent form should be
retained as a clinical research document for future reference to effectively protect the
subjects' personal privacy and data confidentiality.