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

NCT ID: NCT03997227

Last Updated: 2019-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2020-07-02

Brief Summary

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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.

Detailed Description

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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.

ASA I-III, 68 patients between 18-75 years of age were planned to be included in the study. 34 participants were expected to be included in the control and implementation group.

In our study, the ESP block was planned to be applied to the patients in the block group. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol, intravenous paracetamol 1 gr and tramadol 1 mg / kg were determined. Then, every eight hours, paracetamol and contromal infusion.

At the end of the operation, the patients will be determined by the Numeric Rating Scale (NRS) system at the 30th hour, 1st, 6th, 12th and 24th hours after the first hour of the operation. Tramadol PCA and paracetamol are administered every eight hours.

Age, sex, weight, body mass index, application of ESP block, time of surgery, duration of surgery, evaluation of pain in postoperative recovery room and 24-hour follow-up will be recorded when the patient is mobilized and discharged.

It is thought that the ESP block will decrease postoperative pain by providing effective pain control after surgery in patients undergoing lumbar vertebra surgery. In addition, it is thought to accelerate mobilization in the postoperative period and shorten the time of discharge.

Conditions

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Erector Spinae Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Block group

Group Type ACTIVE_COMPARATOR

Erector spinae Block

Intervention Type 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.

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erector spinae Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Sinan ASAR

Principal Investigator, clinical research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinem Sarı

Role: PRINCIPAL_INVESTIGATOR

Aydin Adnan Menderes University

Locations

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Adnan Menderes Univesity

Aydin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sinan Asar

Role: CONTACT

905556316560

Facility Contacts

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Selda Şen

Role: primary

References

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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.

Reference Type RESULT
PMID: 30758122 (View on PubMed)

Other Identifiers

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2019/04

Identifier Type: -

Identifier Source: org_study_id

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