Clinical trial NCT03997227: Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery
Official title: Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery : A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erector Spinae Block
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: NRS(numerical rating scala)
timeFrame: 24 hours
measure: pruritus, nausea and vomiting, use of antiemetics
timeFrame: 24 hours
measure: mobilized , discharged
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes Univesity
Study officials:
affiliation: Aydin Adnan Menderes University
name: Sinem Sarı
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.