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Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block

Primary Purpose

Lumbar Spine Instability, Lumbar Spinal Stenosis, Lumbar Spine Degeneration

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Surgical ESPB
US guided ESPB
Sponsored by
Bursa City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spine Instability focused on measuring Lumbar spinal fusion surgery, Postoperative analgesia, Erector spina plan block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II 2 or 3 levels of posterior lumbar spinal fusion surgery under general anesthesia Exclusion Criteria: history of bleeding diathesis receiving anticoagulant treatment known local anesthetics and opioid allergy infection of the skin at the site of the needle puncture pregnancy or lactation patients who do not accept the procedure

Sites / Locations

  • Mursel Ekinci

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group IE= Surgical Injection ESPB

Group UE= US guided ESPB

Group C = Control group

Arm Description

Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.

Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.

Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia. Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
Postoperative opioid consumption will be evaluated at postoperative 24 h period

Secondary Outcome Measures

Visual analogue scores (VAS)
VAS score (0 = no pain, 10 = the most severe pain felt)

Full Information

First Posted
November 1, 2022
Last Updated
September 20, 2023
Sponsor
Bursa City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05630404
Brief Title
Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block
Official Title
Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block for Pain Management Following Lumbar Spinal Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery. The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery. The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery.
Detailed Description
Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced. Parenteral opioids are generally preferred in the management of acute postoperative pain. However opioids have undesired adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events). Regional anesthesia techniques may be preferred as the use of ultrasound (US) increases in daily anesthesia practice. The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery. The erector spina plane block can be performed by administering local anesthetic solution between the transverse process and the erector spina muscle. The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Instability, Lumbar Spinal Stenosis, Lumbar Spine Degeneration
Keywords
Lumbar spinal fusion surgery, Postoperative analgesia, Erector spina plan block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are three models for this study. The first group is ultrasound guided erector spinae plane block group. The second one is surgical injection erector spinae plane block group. The third one is the no intervention control group.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patient, investigators and the pain nurse who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group IE= Surgical Injection ESPB
Arm Type
Active Comparator
Arm Description
Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.
Arm Title
Group UE= US guided ESPB
Arm Type
Active Comparator
Arm Description
Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.
Arm Title
Group C = Control group
Arm Type
No Intervention
Arm Description
Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia. Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.
Intervention Type
Drug
Intervention Name(s)
Surgical ESPB
Intervention Description
In group IE, transverse processes will be palpated before sewing the surgical incision by the surgery team. The local anesthetic solution will be administered after the needle contacts the transverse process and its location is confirmed by negative aspiration. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 5 mL of solution will be injected the proper injection site. Local anesthetic solution will be injected at 4 levels along the surgical incision line. A dose of 0.25% bupivacaine 20 mL will be injected in each side (total 40 mL). Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.
Intervention Type
Drug
Intervention Name(s)
US guided ESPB
Intervention Description
US guided ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the L3 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted cranio caudal direction and then for correction of the needle 2 ml saline will be enjected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block in each side (total 40 mL). Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Postoperative opioid consumption will be evaluated at postoperative 24 h period
Time Frame
Change from Baseline Opioid Consumption for Postoperative 24 hours.
Secondary Outcome Measure Information:
Title
Visual analogue scores (VAS)
Description
VAS score (0 = no pain, 10 = the most severe pain felt)
Time Frame
postoperative 1, 2, 4, 8, 16 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II 2 or 3 levels of posterior lumbar spinal fusion surgery under general anesthesia Exclusion Criteria: history of bleeding diathesis receiving anticoagulant treatment known local anesthetics and opioid allergy infection of the skin at the site of the needle puncture pregnancy or lactation patients who do not accept the procedure
Facility Information:
Facility Name
Mursel Ekinci
City
Bursa
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigator's will not share IPD
Citations:
PubMed Identifier
31033625
Citation
Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
Results Reference
background
PubMed Identifier
30853517
Citation
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.
Results Reference
background
PubMed Identifier
33596968
Citation
Finnerty DT, Buggy DJ. Efficacy of the erector spinae plane (ESP) block for quality of recovery in posterior thoraco-lumbar spinal decompression surgery: study protocol for a randomised controlled trial. Trials. 2021 Feb 17;22(1):150. doi: 10.1186/s13063-021-05101-2.
Results Reference
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Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block

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