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
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2022
CompletedFirst Submitted
Initial submission to the registry
July 31, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedAugust 4, 2022
August 1, 2022
1 year
July 31, 2022
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of fentanyl and propofol during surgery
Through study completion, an average of 1 year
Secondary Outcomes (5)
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
Study Arms (2)
G1
ACTIVE COMPARATORIntravenous sedation with infiltrative local anaesthesia
G2
EXPERIMENTALIntravenous sedation with bilateral Erector Spine Plane Block
Interventions
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%.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rivne Oblast State Hospital
Rivne, Rivne Oblast, 33000, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 31, 2022
First Posted
August 2, 2022
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
July 5, 2022
Last Updated
August 4, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP