Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy

NCT05999253 | Completed

• 1 other identifier: 05.05.2023/373
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who will undergo herniated disc surgery have serious pain after surgery. In order to minimise this pain and to ensure that they recover more quickly and use less morphine-derived painkillers, we aim to apply two types of painkiller injections before surgery. For this purpose, it is planned to apply painkiller injections on both sides of the level of the herniated disc with sedation before the operation. Afterwards, herniated disc surgery will be performed under general anaesthesia.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  * The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." * Low back pain and leg pain as an extension of the traveling nerve assessed using visual pain scores (VAS) will be evaluated

  assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours

Secondary Outcomes (9)

• Sedation- agitation level

  After extubation]

• Nausea-vomiting

  postoperative 1st, 2nd, 4th, 8th and 24th hours

• Systolic, diastolic and mean arterial pressure monitoring

  before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery

• heart rate monitoring

  before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery

• amount of fentanyl consumed during the operation

  during surgery

Study Arms (2)

Modified thoracolumbar plane block (mTLIP)

Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced. * Patients will be induced with standard general anesthesia and turned to the prone position. * Before the surgical incision, 20 ml of 0.25% bupivacaine 0.25% will be administered bilaterally under ultrasound guidance only once. * 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used) * Plane block applications will be performed by anaesthesiologists with at least 5 years of experience

Procedure: Modified thoracolumbar plane block (mTLIP)

Erector spinae plane block (ESP)

Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process. * Patients will be induced with standard general anesthesia and turned to the prone position. * Before the surgical incision, 20 ml of 0.25% bupivacaine will be administered bilaterally under ultrasound guidance only once. * 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used) * Plane block applications will be performed by anaesthesiologists with at least 5 years of experience

Procedure: Erector spinae plane block (ESP)

Interventions

Modified thoracolumbar plane block (mTLIP) PROCEDURE

Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced. * 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used) * to be administered only approximately 20-30 minutes before the onset of anaesthesia.

Also known as: Plane block

Modified thoracolumbar plane block (mTLIP)

Erector spinae plane block (ESP) PROCEDURE

Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process. * 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used) * to be administered only approximately 20-30 minutes before the onset of anaesthesia

Also known as: Plane block

Erector spinae plane block (ESP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients to be operated for 1 or 2 level lumbar disc herniation.

You may qualify if:

• Patients between 18-70 years of age, ASA I-III, scheduled for Lumbar Disc Herniation operation under general anaesthesia.

You may not qualify if:

• ASA \>III body mass index (BMI) \> 35 kg/m2 known allergy to local anaesthetics presence of preoperative chronic pain presence of coagulopathy those who are unable to give written consent non-voluntary patients

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related Publications (1)

• Ciftci B, Ekinci M, Celik EC, Yayik AM, Aydin ME, Ahiskalioglu A. Ultrasound-Guided Erector Spinae Plane Block versus Modified-Thoracolumbar Interfascial Plane Block for Lumbar Discectomy Surgery: A Randomized, Controlled Study. World Neurosurg. 2020 Dec;144:e849-e855. doi: 10.1016/j.wneu.2020.09.077. Epub 2020 Sep 18.

  PMID: 32956890 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Cem K. Kaçar, Assoc.Prof

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Spesialist

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: October 3, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 9, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)