Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery

NCT03997227 | Unknown DMC

• 1 other identifier: 2019/04
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay. The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

Conditions

Erector Spinae Block

Outcome Measures

Primary Outcomes (3)

• NRS(numerical rating scala)

  Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours

  24 hours

• pruritus, nausea and vomiting, use of antiemetics

  each criterion is reported as present or absent each criterion is reported as present or absent

  24 hours

• mobilized , discharged

  each criterion is reported as when the patient is mobilized and when he is discharged

  7 days

Study Arms (2)

Block group

ACTIVE COMPARATOR

Procedure: Erector spinae Block

control group

NO INTERVENTION

Interventions

Erector spinae Block PROCEDURE

After anesthesia and surgical procedures, a bilateral ESP block with ultrasound guidance will be applied from the T10 level at the middle line 3 cm lateral. Prior to the block, with povidone iodine, the T10 transverse protrusion will be determined by using linear ultrasound probe. The local anesthetic will be applied between the transverse projection and the erector spina muscle with the help of an isolated needle designed for peripheral block operations. Without local anesthesia, the location of the needle with saline will be confirmed by hydrodissection. After confirming the location of the needle, 20 ml of LA and saline mixture will be applied and the same procedure will be repeated in the control. A total of 40 ml of LA, 20 ml of bupivacaine 0.5%, 10 ml of lidocaine 2%, 10 ml of saline will be composed of saline.

Block group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients
• ASA I-III,
• Aged 18-75 years
• underwent lumbar spine surgery under elective conditions

You may not qualify if:

• Presence of contraindications to LA agents used in this study
• Use of chronic opioids,
• Psychiatric disorders.
• Surgical procedures that lasted \<60 minutes or\> 300 minutes
• The presence of infection at the injection area.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes Univesity

Aydin, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.

  PMID: 30758122 RESULT

Study Officials

• Sinem Sarı

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinan Asar

CONTACT

905556316560; s.asar@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, clinical research

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 25, 2019
• Study Start: May 2, 2019
• Primary Completion: May 2, 2020
• Study Completion: July 2, 2020
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)