- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04886375
Comparison of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery
May 10, 2021 updated by: Gökhan Sertçakacılar, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
The Effect of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery
This study aims to compare the effects of the erector spinae plan block (ESP) and modified pectoral nerve block (PECS II) on postoperative analgesia in patients undergoing video- assisted thoracoscopic surgery (VATS).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
55 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups.
(26 patients in each of the PECS and ESP groups).
Three patients were excluded from the study because thoracotomy was performed.
ESP block was performed for ESP group and a modified pectoral nerve block was performed in the PECS group.
Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device.
Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure.
Perioperative remifentanil use, numeric rating scale values, time of the first analgesic request, and additional analgesic consumption were recorded.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bakirkoy
-
Istanbul, Bakirkoy, Turkey, 34147
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages of 18-65
- Patients who will undergo VATS
- ASA I-II-III patients
Exclusion Criteria:
- Clinically diagnosis of spinal or chest wall deformity or pathology
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
- Clinically diagnosis of psychiatric disease
- Coagulopathy
- Patients with ASA IV-V
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: esp group
The investigators performed erector spina plane block to that patient group for postoperative analgesia
|
The investigators performed erector spina plane block to that patient group for postoperative analgesia
|
Active Comparator: pecs group
The investigators performed modified pectoral nerve block to that patient group for postoperative analgesia
|
The investigators performed modified pectoral block to that patient group for postoperative analgesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative 24-hours total morphine consumption
Time Frame: 24 hours postoperatively
|
This will be measured only one time by pca device at the 24th hour after surgery.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS scores of patients
Time Frame: 24 hours postoperatively
|
NRS at 0, 1, 2, 4, 8, 12 ve 24th hours
|
24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
May 10, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 14, 2021
Study Record Updates
Last Update Posted (Actual)
May 14, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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