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Acute PainNCT05483647

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

A study testing Local infiltrative anaesthesia and Erector spine plane block in people with Acute Pain and Chronic Pain, run by Lviv National Medical University at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Acute Pain, Chronic Pain, Postoperative Pain
What is being tested?
Local infiltrative anaesthesia and Erector spine plane block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUkraine
Study dates
1 Jan 2021to 5 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

Ukraine1 site
  • Rivne Oblast State Hospital

    Rivne, Rivne Oblast, 33000

Other trials in Ukraine

About this study

Official title: 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.

Read the 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.

Being tested
Local infiltrative anaesthesia, Erector spine plane block
Keywords
ERECTOR SPINE PLANE BLOCK, Regional anesthesia, LOCAL INFILTRATION ANAESTHESIA, TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY
Medical subject headings
Acute Pain, Chronic Pain, Pain, Postoperative, Hyperalgesia, Intraoperative Complications, Postoperative Nausea and Vomiting, Postoperative Cognitive Complications, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local infiltrative anaesthesiaProcedure or surgery

    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%.

  • Erector spine plane blockProcedure or surgery

    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.

Study groups in NCT05483647
Study groupRoleWhat they receive
G1Active comparatorIntravenous sedation with infiltrative local anaesthesia
Receives: Procedure: Local infiltrative anaesthesia
G2ExperimentalIntravenous sedation with bilateral Erector Spine Plane Block
Receives: Procedure: Erector spine plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of fentanyl and propofol during surgery

    Measured: Through study completion, an average of 1 year

Secondary outcomes (5)
  1. Adverse events during sedation using World Society of Intravenous Anaesthesia adverse sedation event reporting tool

    Measured: Through study completion, an average of 1 year

  2. Level of postoperative sedation with Richmond Agitation-Sedation Scale

    Measured: Through study completion, an average of 1 year

  3. Intensity of pain after surgery using a visual analogue scale

    Measured: On hour after surgery

  4. The mechanical pain threshold with von Frey monofilaments measured on both lower extremities

    Measured: Baseline, on the 1st day after surgery

  5. Satisfaction with analgesia using 5-point Likert scale.

    Measured: On the 5st day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start1 Jan 2021
  3. Primary completion1 Jan 2022
  4. Study completion5 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05483647
Sponsor's protocol ID
LNMY-FPGE- ANESTHESIOLOGY-TPED
Status last verified
Aug 2022
First submitted
31 Jul 2022
Last updated
4 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Local infiltrative anaesthesia and Erector spine plane block in people with Acute Pain and Chronic Pain, run by Lviv National Medical University at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of fentanyl and propofol during surgery (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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