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

Primary Purpose

Acute Pain, Chronic Pain, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Local infiltrative anaesthesia
Erector spine plane block
Sponsored by
Lviv National Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring ERECTOR SPINE PLANE BLOCK, Regional anesthesia, LOCAL INFILTRATION ANAESTHESIA, TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rivne Oblast State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

G1

G2

Arm Description

Intravenous sedation with infiltrative local anaesthesia

Intravenous sedation with bilateral Erector Spine Plane Block

Outcomes

Primary Outcome Measures

Amount of fentanyl and propofol during surgery

Secondary Outcome Measures

Adverse events during sedation using World Society of Intravenous Anaesthesia adverse sedation event reporting tool
Level of postoperative sedation with Richmond Agitation-Sedation Scale
Intensity of pain after surgery using a visual analogue scale
The mechanical pain threshold with von Frey monofilaments measured on both lower extremities
Satisfaction with analgesia using 5-point Likert scale.

Full Information

First Posted
July 31, 2022
Last Updated
August 2, 2022
Sponsor
Lviv National Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05483647
Brief Title
ERECTOR SPINE PLANE BLOCK VERSUS LOCAL INFILTRATION ANAESTHESIA FOR TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY
Official Title
Erector Spine Plane Block as a Component of General Anesthesia in Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lviv National Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Chronic Pain, Postoperative Pain, Anesthesia, Regional Anesthesia Morbidity, Anesthesia, Local, Anesthesia Complication, Hyperalgesia, Intraoperative Complications, Intraoperative Neurological Injury, Intraoperative Injury, Postoperative Nausea and Vomiting, Postoperative Cognitive Dysfunction, Neuropathic Pain
Keywords
ERECTOR SPINE PLANE BLOCK, Regional anesthesia, LOCAL INFILTRATION ANAESTHESIA, TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1
Arm Type
Active Comparator
Arm Description
Intravenous sedation with infiltrative local anaesthesia
Arm Title
G2
Arm Type
Experimental
Arm Description
Intravenous sedation with bilateral Erector Spine Plane Block
Intervention Type
Procedure
Intervention Name(s)
Local infiltrative anaesthesia
Intervention Description
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%.
Intervention Type
Procedure
Intervention Name(s)
Erector spine plane block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount of fentanyl and propofol during surgery
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Adverse events during sedation using World Society of Intravenous Anaesthesia adverse sedation event reporting tool
Time Frame
Through study completion, an average of 1 year
Title
Level of postoperative sedation with Richmond Agitation-Sedation Scale
Time Frame
Through study completion, an average of 1 year
Title
Intensity of pain after surgery using a visual analogue scale
Time Frame
On hour after surgery
Title
The mechanical pain threshold with von Frey monofilaments measured on both lower extremities
Time Frame
Baseline, on the 1st day after surgery
Title
Satisfaction with analgesia using 5-point Likert scale.
Time Frame
On the 5st day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rivne Oblast State Hospital
City
Rivne
State/Province
Rivne Region
ZIP/Postal Code
33000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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