- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997227
Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery
Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery : A Randomized Control Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aydın, Turkey
- Recruiting
- Adnan Menderes Univesity
-
Contact:
- Selda Şen
- Email: drseldasen@yahoo.com
-
Principal Investigator:
- Sinem Sarı
-
Principal Investigator:
- Sinan Asar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Active Comparator: Block group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
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
|
24 hours
|
mobilized , discharged
Time Frame: 7 days
|
each criterion is reported as when the patient is mobilized and when he is discharged
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sinem Sarı, Aydin Adnan Menderes University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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