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Clinical Trials/NCT03997227
NCT03997227
Unknown
Not Applicable

Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery : A Randomized Control Trial

Aydin Adnan Menderes University1 site in 1 country68 target enrollmentMay 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erector Spinae Block
Sponsor
Aydin Adnan Menderes University
Enrollment
68
Locations
1
Primary Endpoint
mobilized , discharged
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2019
End Date
July 2, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aydin Adnan Menderes University
Responsible Party
Principal Investigator
Principal Investigator

Sinan ASAR

Principal Investigator, clinical research

Aydin Adnan Menderes University

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.

Outcomes

Primary Outcomes

mobilized , discharged

Time Frame: 7 days

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

pruritus, nausea and vomiting, use of antiemetics

Time Frame: 24 hours

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

NRS(numerical rating scala)

Time Frame: 24 hours

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

Study Sites (1)

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