Effect of Regional Anesthesia on Enhanced Recovery After Spine Surgeries

Study Overview
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Brief Summary
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This study will be carried out on 80 patients who will be presented for different spine surgeries under general anesthesia and regional anesthesia technique in Tanta university hospitals. The study was approved by the research ethics committee of the faculty of medicine. Patients will be admitted to the OR where induction of general anesthesia was started and then, the patients will be randomly distributed into two equal groups; - Group I (40 patients) (ESP block): patients in this group will receive ESP block after induction of general anesthesia. Group II (40 patients) (TLIP block): patients in this group will receive TLIP block after induction of general anesthesia Measurements; - The length of hospital stay as the primary outcome Postoperative pain scores and opioid consumption as the Secondary outcome

Detailed Description
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This prospective randomized double-blind study will be carried out on 80 adult patients who will be presented for different spine surgeries in Tanta university hospitals after obtaining the approval from the institutional Ethical Committee, informed written consent will be obtained from all the participants. Patients will be randomly classified using a computer-generated software of randomization into 2 groups: Group I (40 patients) (ESP block): patients in this group will receive ESP block after induction of general anesthesia. Group II (40 patients) (TLIP block): patients in this group will receive TLIP block after induction of general anesthesia Anesthetic technique The patients will be assessed preoperatively in the anesthesia clinic. On arrival of patients to the preparation room, an intravenous line will be established and the patient will be connected to a monitor. All the patients will receive pheniramine hydrogen maleate 45.5 mg intravenous as an antihistamine, Cefazolin30 mg/kg, and 40 mg pantoprazole. Induction of anesthesia will be carried out by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and atracurium 0.5 mg/kg to facilitate tracheal intubation. After securing the airway through a suitable sized endotracheal tube, the patient was connected to a mechanical ventilator with its parameters adjusted to maintain the end-tidal carbon dioxide 34-38 mmHg. Maintenance of the anesthesia was performed by isoflurane 1.2 % and incremental doses of atracurium 0.1 mg/kg. A temperature probe was inserted in the nasopharynx for core temperature monitoring. The depth of anesthesia was monitored by the bispectral index (Covidien, Mansfield, MA, USA). The BIS values were kept 40-60. An additional bolus dose of fentanyl 0.5 ug/kg was used in case of increase BIS more than 60 or increase in the heart rate or mean arterial pressure by more than 15 % of the baseline values. All patients received tranexamic acid 30 mg/kg through intravenous infusion. Before skin incision, patients of group I will receive ultrasound-guided ESP block, while patients in group II will receive ultrasound guided TLIP block. At the end of the surgery, the isoflurane was switched off with reversal of muscle relaxation and awake tracheal extubation and transfer of the patient to the recovery room for postoperative monitoring and supplementation of oxygen through a nasal cannula (2-3 L/min). All the patients will receive 4 mg dexamethasone I .v after induction of anesthesia and 4 mg of ondansetron i.v at the end of the surgery to guard against postoperative nausea and vomiting. All patients will receive paracetamol 1 g every 6 hours daily If a patient complained about pain score of more than 3, rescue analgesics of IV ketorolac 30 mg and morphine 3 mg will be administered. Morphine PCA will be started with bolus dose of 1mg, a lockout interval of 7 min and a maximum dose of 34.2 mg per 4 h. Morphine PCA will be started on-demand after the time to first analgesic request and continued on the patient's need. Measurements will be obtained by an assistant nurse not participating in the study and blinded to its groups. Patient age, ASA class, BMI, duration of surgery, and number of levels operated. The presence of comorbidities, smoking, or alcohol abuse. block performance time. The length of hospital stays after surgery and time to first ambulation Postoperative Numerical rating score (NRS) every 2 hours in the first six hours, then every 4 h till 24 h. When NRS scores reach 4 or more, 3 mg of i.v morphine will be given and can be repeated if required with a calculation of the total postoperative morphine consumption in mg in the first 24 hours after surgery and the time to the first request of rescue analgesia.(Secondary outcomes) Intraoperative fentanyl consumption. Postoperative analgesic consumption. Time of return of bowel function. The patients will be asked to grade their degree of satisfaction regarding postoperative analgesia using a 4-point scale, where 4 = very satisfied, 3 = satisfied, 2 = dissatisfied, and 1 = very dissatisfied. The incidence of postoperative complications including nausea and vomiting, pruritis, respiratory depression, and sedation.

Official Title
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Effect of Thoracolumbar Interfacial Plane Block or Erector Spinae Plane Block on the Enhanced Recovery After Spine Surgeries: Prospective Randomized Double-blind Study

Conditions
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ERAS

Intervention / Treatment
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* Procedure: Erector spinae plane block
* Procedure: Throacolumbar interfacial plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for spine surgeries. Exclusion Criteria: Patient refusal Body mass index (BMI) less than 18 or higher than35 kg/m2 Pregnant History of relevant allergy to related perioperative medications Previous lumbar spine surgery Existing contraindications to nerve block such as coagulopathy, local and systemic infection Hepatic or renal insufficiency Chronic opioid use

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>patients in this group will receive Erector spinae plane block after induction of general anesthesia. | Procedure: Erector spinae plane block<br>* While patients in the prone position, 1.4-5.1 MHz low-frequency probe (C5-1s convex transducer) will be first placed in a longitudinal orientation in the midline to identify the spinous process of at the appropriate lumbar level, then it will be scanned laterally about 2-3 cm until visualization of the paraspinal muscles and the transverse process at the same time. After standard sterilization, a 21-G short bevel nerve block needle will be advanced in a cephalad-to-caudal direction, in-plane under real- time ultrasound guidance, through skin, subcutaneous tissue, and erector spinae muscles until reaching the transverse process. After negative aspiration of blood or cerebral spinal fluid, a small volume of local anesthetic was injected to confirm the position of the needle tip between the erector spinae muscles and the transverse process. A total of 20 ml of 0.0.25% plain bupivacaine will be incrementally injected with intermittent negative aspiration on each side.<br>|
| Experimental: Group II<br>patients in this group will receive thoracolumbar interfascial plane block after induction of general anesthesia | Procedure: Throacolumbar interfacial plane block<br>* USG-guided TLIP block will be performed using a high-frequency linear probe while the patient in prone position. The probe will be covered with sterile sheath positioned transversally in a midline position at approximately the level of the 3rd lumbar vertebra (L3). The corresponding spinous process and interspinal muscles will be identified, and the probe will be slid laterally to identify the multifidus (MF) muscle and longissimus (LG) muscle. Sliding the probe from midline to laterally helps in the correct identification of various muscles. After identifying the muscles, TLIP block will be performed aseptically on both sides of L3 vertebra. Under ultrasound guidance, an insulated echogenic needle will be inserted in-plane in a lateral to medial orientation in-plane USG guided through the belly of LG toward the MF. When needle reach deep to middle of MF/LG interface, 20 ml 0.25% bupivacaine will be injected after negative aspiration. The block will be administered bilaterally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | The time interval in days from the day of the surgery till discharge of the patient from the hospital. | Within 7 days of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain scores | Postoperative Numerical rating score (NRS) every 2 hours in the first six hours, then every 4 h till 24 h. When NRS scores reach 4 or more, 3 mg of i.v morphine will be given and can be repeated if required with calculation of the total postoperative morphine consumption in mg in the first 24 hours after surgery and the time to the first request of rescue analgesia | Within the first 24 hours after surgery | 
| The postoperative opioid consumption | The total dose of morphine consumed in the first 24 hours after surgery | Within the first 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine surgery, Length of hospital stay, ERAS, Regional analgesia