Sacral Erector Spinae Plane Block(ESPB) in Lumbar Discectomy

NCT06028100 | Completed

• 1 other identifier: 2023/06
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies have shown that sacral espb blocks the dorsal ramus of spinal nerves. In lumbar discectomy operations, innervation of all tissues where pain occurs is provided by the dorsal ramus of the nerves. Based on this information, it was thought that sacral espb would be effective in lumbar discectomies. The investigators wanted to look at the effects of sacral erector spinae plane block on postoperative pain and opioid consumption in lumbar discectomy operations. There is no randomised controlled study on sacral espb in the literature. The researchers think that the results of the study are promising. Sacral espb is an easy-to-administer block with a low risk of complications and can be used effectively in lumbar discectomy analgesia.

Conditions

Pain Management

Keywords

regional block; erector spinae plane block; pain management

Outcome Measures

Primary Outcomes (2)

• Patient pain scores

  Visual Analog Scala (0:No pain 10: Worst pain possible)

  24 hours

• Patient total opioid consumption

  The number of patient controlled analgesia device boluses doses

  24 hours

Secondary Outcomes (2)

• Nausea-vomiting

  24 hours

• Patient satisfaction

  24. hours

Study Arms (2)

espb group

ACTIVE COMPARATOR

The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side

Procedure: sacral erector spinae plane block

control group

NO INTERVENTION

The second group had no any block

Interventions

sacral erector spinae plane block PROCEDURE

espb from bilateral sacral level 2 with 20 ml %0,25 bupivacaine

espb group

Eligibility Criteria

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

You may qualify if:

• patients over 18 years of age,
• American Society of Anesthesiology(ASA) status 1-3 group

You may not qualify if:

• Patients who refused to participate in the study
• Patients with known neuromuscular and haematological diseases
• Allergy to local anaesthetics
• Contraindications to regional anaesthesia
• Anatomical changes in the lumbo-sacral region

Sponsors & Collaborators

• Bilge Olgun Keles: lead

Study Sites (1)

Giresun Research and Training Hospital

Merkez, Giresun, 28100, Turkey (Türkiye)

Location

Related Publications (5)

• Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.

  PMID: 30853517 RESULT

• Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.

  PMID: 26288544 RESULT

• Kilicaslan A, Aydin A, Kekec AF, Ahiskalioglu A. Sacral erector spinae plane block provides effective postoperative analgesia for pelvic and sacral fracture surgery. J Clin Anesth. 2020 May;61:109674. doi: 10.1016/j.jclinane.2019.109674. Epub 2019 Dec 4. No abstract available.

  PMID: 31812367 RESULT

• Chakraborty A, Chakraborty S, Sen S, Bhatacharya T, Khemka R. Modification of the sacral erector spinae plane block using an ultrasound-guided sacral foramen injection: dermatomal distribution and radiocontrast study. Anaesthesia. 2021 Nov;76(11):1538-1539. doi: 10.1111/anae.15549. Epub 2021 Jul 26. No abstract available.

  PMID: 34309009 RESULT

• Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.

  PMID: 35431750 RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bilge Olgun Keleş, M.D.

  Giresun University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient did not know what was done to him/her because the block was performed before the patient woke up. The investigator who questioned postoperative pain and opioid consumption did not know to whom the block was performed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: 54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up.A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.And total consumption of analgesic and rescue analgesics were recorded.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: June 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)