ERECTOR SPINE PLANE BLOCK VERSUS LOCAL INFILTRATION ANAESTHESIA FOR TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY

Erector Spine Plane Block as a Component of General Anesthesia in Spine Surgery

The main aim of our study was to test the hypothesis that Erector spine plane block (ESP) with sedation will provide the similar employment of fentanyl and propofol during surgery as an infiltrative local anaesthesia with sedation. The primary endpoint was the quantity of fentanyl and propofol during surgery.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Postoperative Pain; Anesthesia, Local; Postoperative Cognitive Dysfunction; Acute Pain; Neuropathic Pain; Anesthesia; Postoperative Nausea and Vomiting; Intraoperative Complications; Hyperalgesia; Regional Anesthesia Morbidity; Anesthesia Complication; Intraoperative Injury; Intraoperative Neurological Injury
• Intervention / Treatment: Procedure: Local infiltrative anaesthesia; Procedure: Erector spine plane block

Detailed Description

Primary outcome: amount of fentanyl and propofol during surgery. Secondary outcomes: adverse events during sedation using World Society of Intravenous Anaesthesia (SIVA) adverse sedation event reporting tool [15], level of postoperative sedation with Richmond Agitation-Sedation Scale (RASS), intensity of pain after surgery using a visual analogue scale (VAS), the mechanical pain threshold (MPT) with von Frey monofilaments measured on both lower extremities, satisfaction with analgesia using 5-point Likert scale.

In both groups, intraoperative analgesia was provided by fentanyl, intraoperative sedation by propofol. Fentanyl was administered to the patients of booth groups in the case of low back pain complaint and/or increasing in heart rate and blood pressure more than 20% of baseline in the dose of 50 μg. If case of sharp shooting pain in lower extremity the surgeon changed the position of the endoscope in order not to irritate the spinal cord root, fentanyl was not administrated.

After performing the local infiltrative anaesthesia or ESP, propofol was given by target-controlled infusion based on the propofol pharmacokinetic parameters reported by Eleveld 2.1 [16]. The initial propofol plasma concentration target was 1,0 μg ml-1 in both groups (we used iTIVA plus Anaesthesia software v5.2.3 to predict the propofol concentrations). Subsequently, the infusion rate of propofol was changed in order to reach not less than 2-3 score levels of modified observer's assessment of alertness/sedation scale (MOAA/S).

During procedural sedation was used World SIVA adverse sedation event reporting tool. All five steps which require this tool were completed. If there were one or more adverse events associated with this sedation encounter (minimal risk descriptors, minor risk descriptors, sentinel risk descriptors or other) they were described. Interventions that were performed to treat the adverse events and the outcomes of the adverse events were also noted.

After the discharge from the operating room to postoperative ward, the level of postoperative sedation was accessed using RASS. Two hours after surgery intensity of pain and the mechanical pain threshold were obtained as well as satisfaction with analgesia using 5-point Likert scale.

To determine the mechanical pain threshold after surgery Von Frey monofilaments were used. The set consists of 20 nylon filaments of different thicknesses in ascending order. Patients were asked to lie down on their backs, close their eyes and inform the doctor when they felt a clear point of contact with the skin. Monofilaments were pressed against the skin of the middle third of the palmar surface of the forearm at an angle of 90 ° until the filament bends for 2 seconds. Monofilaments were used in ascending order with an interval of 10 seconds.

All patients in the operating room received paracetamol, dexketoprofen, ondansetron, dexamethasone, and tranexamic acid. In prone position, before the skin incision, patients in G1 underwent local infiltrative anaesthesia et the level of incision. The skin, subcutaneous tissue and muscles up to the foramen intervertebral were anesthetized by the surgeon employing forty millilitre solution of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018%. Patients in G2 underwent bilateral ESP. The transverse vertebral process of the required level of spine was identified using the mobile C-arm X-ray System. When the tip of the 22G needle reached to the transverse vertebral process 3 cm lateral to the spinous process, a solution of 40 millilitres of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018% was injected under the erector spinae muscle bilaterally. For postoperative analgesia, patients in both groups received nonsteroidal anti-inflammatory drugs (paracetamol in combination with dexketoprofen) every six hours. Thromboprophylaxis was administered based on the risk of thromboembolic complications.

Duration of observation of the patients was proceed until discharge from the hospital.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Rivne Region
    • Rivne, Rivne Region, Ukraine, 33000
      • Rivne Oblast State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: informed consent of the patient to participate in the study, intervertebral hernia that require transforaminal percutaneous endoscopic discectomy, and the absence of known allergies to local anaesthetics.

Exclusion Criteria: refusal to participate in the study both at the beginning of the study and at any stage of the study, physical status according to the ASA classification III and more, age more than 50 years old, body mass index (BMI) more than 30 kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: G1; Intravenous sedation with infiltrative local anaesthesia	Procedure: Local infiltrative anaesthesia; In prone position, before the skin incision, patients in G1 underwent local infiltrative anaesthesia et the level of incision. The skin, subcutaneous tissue and muscles up to the foramen intervertebral were anesthetized by the surgeon employing forty millilitre solution of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018%.
EXPERIMENTAL: G2; Intravenous sedation with bilateral Erector Spine Plane Block	Procedure: Erector spine plane block; The transverse vertebral process of the required level of spine was identified using the mobile C-arm X-ray System. When the tip of the 22G needle reached to the transverse vertebral process 3 cm lateral to the spinous process, a solution of 40 millilitres of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018% was injected under the erector spinae muscle bilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of fentanyl and propofol during surgery	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events during sedation using World Society of Intravenous Anaesthesia adverse sedation event reporting tool	Through study completion, an average of 1 year
Level of postoperative sedation with Richmond Agitation-Sedation Scale	Through study completion, an average of 1 year
Intensity of pain after surgery using a visual analogue scale	On hour after surgery
The mechanical pain threshold with von Frey monofilaments measured on both lower extremities	Baseline, on the 1st day after surgery
Satisfaction with analgesia using 5-point Likert scale.	On the 5st day after surgery

Collaborators and Investigators

• Sponsor: Lviv National Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): July 5, 2022

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (ACTUAL): August 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Regional anesthesia; ERECTOR SPINE PLANE BLOCK; LOCAL INFILTRATION ANAESTHESIA; TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurocognitive Disorders; Signs and Symptoms, Digestive; Neuromuscular Diseases; Peripheral Nervous System Diseases; Cognition Disorders; Sensation Disorders; Somatosensory Disorders; Nausea; Vomiting; Chronic Pain; Neuralgia; Wounds and Injuries; Cognitive Dysfunction; Postoperative Cognitive Complications; Acute Pain; Postoperative Nausea and Vomiting; Trauma, Nervous System; Intraoperative Complications; Hyperalgesia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: LNMY-FPGE- ANESTHESIOLOGY-TPED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No