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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997227
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sinan ASAR, Aydin Adnan Menderes University

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.


Condition or disease Intervention/treatment Phase
Erector Spinae Block Procedure: Erector spinae Block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery : A Randomized Control Trial
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 2, 2020
Estimated Study Completion Date : July 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Block group Procedure: 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.

No Intervention: control group



Primary Outcome Measures :
  1. 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

  2. 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

  3. mobilized , discharged [ Time Frame: 7 days ]
    each criterion is reported as when the patient is mobilized and when he is discharged



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997227


Contacts
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Contact: Sinan Asar 905556316560 s.asar@hotmail.com

Locations
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Turkey
Adnan Menderes Univesity Recruiting
Aydın, Turkey
Contact: Selda Şen       drseldasen@yahoo.com   
Principal Investigator: Sinem Sarı         
Principal Investigator: Sinan Asar         
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
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Principal Investigator: Sinem Sarı Aydin Adnan Menderes University
Publications of Results:
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Responsible Party: Sinan ASAR, Principal Investigator, clinical research, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03997227    
Other Study ID Numbers: 2019/04
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms