Erector Spinae Plane Block and Ankle and Foot Surgery
Condition: Pain; Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      Regional anesthesia is commonly used in orthopedic and surgical procedures in ankle and foot
      surgery to manage pain. The ultrasound-guided nerve block is a safe and effective regional
      anesthesia technique that provides effective pain management, decreasing opioid consumption.

      Postoperative pain management may be challenging and requires a multimodal approach. Regional
      anesthesia techniques in the pediatric ankle and foot surgery population are frequently used
      in postoperative pain management due to ultrasonography's increased experience and
      accessibility.

      Erector spinae plane block (ESP) is a relatively new regional anesthesia technique that
      provides analgesia covering spinal nerves' dorsal and ventral rami. There are few cases
      reports in the literature on the use of ESP block for lower limb surgery, for which it has a
      promising potential for future indication.

      The erector spinae plane block is a safe and effective regional anesthesia technique, which
      has earned new indications perioperatively since its description.
    

Detailed description: 
      This single-center study was a prospective randomized controlled trial, using parallel groups
      with a 1:1 allocation ratio. Eligible patients were identified by the surgeon and invited to
      participate in the study. If the patient wished to participate in the study, informed consent
      was obtained. The patient was informed of the study's nature, especially that the patient
      would be randomized to receive an ESPB or a sham block before the procedure. A computerized
      randomization program (permuted block randomization) was used to create the allocation before
      the beginning of the study. Research staff not involved in the recruitment process or the
      study's conduct randomized patients at the time of admission to the clinic. Randomization
      allocation was 1:1 between treatment and control groups. Apart from the anesthesiologists who
      performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to
      randomization throughout the study period. The outcome parameters were recorded through a
      study nurse who was not involved in the patients' care.

      All patients received standardized anesthesia, and all blocks were performed by 2
      anesthesiologists who were trained in this technique. A large-bore intravenous (IV) line was
      placed, and patients received midazolam 1 to 2 mg IV for anxiolysis.

      Anesthesia was induced with fentanyl 2 mcg.kg-1 and propofol 2 mg.kg-1 followed by atracurium
      0.5 mg.kg-1 . After intubation, anesthesia was maintained with isoflurane (1 MAC) and
      atracurium 0.1mg.kg-1 as a maintenance dose every 30 min until the end of the procedure.
      After emerging from anesthesia, patients were transferred to the postanesthesia care unit
      (PACU) for a 2-h observation period. Patients were discharged from the PACU when they
      achieved a modified Aldrete score ≥ 9.10. Postoperative analgesia was provided in both groups
      immediately after surgery by PCA fentanyl pump, then oral acetaminophen 1 g four times a day.
      The criteria to stop the fentanyl titration protocol included satisfactory pain control,
      increased sedation (Ramsay sedation scale >2), decreased respiratory rate.

      Statistical Analyses The sample size was estimated to achieve a power of 0.8 to detect a
      supposed medium effect size of 0.7 in between the two groups regarding total morphine
      consumption, with a 2-sided significance level of .05 and allocation ratio of 1. Thirty
      patients in each group were required. Allowing for a 10% loss, 34 patients were recruited in
      each group, for a total of 68 patients. The sample size was determined using G*Power software
      (version 3.1.9.7).

      Descriptive statistics, including age, sex, body mass index, baseline pain scores, procedure
      type, traction time, and procedure time, were comparatively analyzed between the groups.
      Categorical data were compared with chi-squared and Fisher's exact tests as appropriate.
      Continuous data were compared with a 2-sided t test (for normally distributed data) and
      Wilcoxon rank-sum test (for non normally distributed data). For all analyses (primary and
      secondary measures), a P value of .05 was used to determine statistical significance.
      Statistical analyses were conducted using SPSS version 28 (Addinsoft, Paris, France).
    

Intervention name(s): Ultrasound; Bupivacaine Hydrochloride; saline solution; Needle
Intervention type(s): Device; Drug; Drug; Device
Intervention description(s): A linear US transducer (Phillips-Saronno Italy) was placed vertically 3 cm lateral to the midline to visualize back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, as well as the TPs with shimmering pleura in between.; The ESP block group underwent US-guided ESP block at L4 vertebrae level with 20 ml of bupivacaine 0.25%.; The control group underwent the same procedure but had a sham injection (20 ml of saline).; A 22-gauge short bevel needle (Spinocan, B. Braun Melsungen AG, Germany) was inserted in the cranial-caudal direction towards the TP in-plane with the US transducer until the needle touched the TP crossing all three muscles.
Other intervention name(s): Linear transducer; Local anesthetic; Saline isotonic 0.9%
Intervention MeSH terms: Bupivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Erector spinae block; Ankle and foot surgery; Postoperative analgesia