Clinical trial NCT05463809: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Foot Ankle Injuries
Keywords: nerve block
Continuous Gastrocnemius plane block
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Area under the pain intensity-time curve
timeFrame: Up to 48 hours postoperative
Secondary outcomes:
measure: Percentage of subjects without remedial analgesics
timeFrame: Up to 48 hours postoperative
measure: The cumulative amount of remedial analgesic drugs (oxycodone) used
timeFrame: Up to 48 hours postoperative
measure: Number of remedial analgesia
timeFrame: Up to 48 hours postoperative
measure: Number of effective patient controlled analgesia (PCA) compressions
timeFrame: Up to 48 hours postoperative
measure: The proportion of the number of invalid presses to the total presses
timeFrame: Up to 48 hours postoperative
measure: Total number of patient controlled analgesia (PCA) presses
timeFrame: Up to 48 hours postoperative
Other outcomes:
measure: The incidence of muscle strength and sensory abnormalities in the affected limb
timeFrame: Up to 48 hours postoperative
measure: The incidence of adverse reactions, such as nausea, vomiting, and neurological complications
timeFrame: Up to 48 hours postoperative
measure: First time to get out of bed
timeFrame: Up to 48 hours postoperative
measure: The incidence of adverse events
timeFrame: Up to 48 hours postoperative
measure: Patient satisfaction score
timeFrame: Up to 48 hours postoperative
measure: The incidence of outbreak pain
timeFrame: Up to 7 days postoperative
Locations:
Study officials:
References:
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