- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217292
Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery
Evaluation of the Effect of Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).
Exclusion Criteria:
- Previous history of opioid use preoperatively,
- Allergy to local anesthetics,
- The presence of any systemic infection,
- Uncontrolled arterial hypertension,
- Uncontrolled diabetes mellitus.
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 |
---|---|
Experimental: Group S
IV patient-controlled analgesia (PCA) tramadol+Serratus Anterior Plane Block(SAPB) Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. 20 mL of bupivacaine at a concentration of 0.25% to between serratus anterior and intercostal muscle using the in-line technique for SAPB. |
|
Active Comparator: Group T
IV patient-controlled analgesia (PCA) tramadol Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg.
Maximum daily dose was set at 400 mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale
Time Frame: Postoperative 24 hours
|
Visual Analogue Scale was used for pain
|
Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tramadol consumption
Time Frame: Postoperative 24 hour
|
tramadol consumption
|
Postoperative 24 hour
|
Ramsay sedation scale (RSS)
Time Frame: 24 hours
|
Ramsay sedation scale (RSS)
|
24 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
side effect profile
Time Frame: 24 hours
|
side effect profile
|
24 hours
|
additional analgesic use
Time Frame: 24 hours
|
additional analgesic use
|
24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Burcu Metin Ökmen, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2011-KAEK-25 2016/13-06
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.
Clinical Trials on Nerve Block
-
Lawson Health Research InstituteUnknownInferior Alveolar Nerve Block | Greater Palatine Nerve BlockCanada
-
Diskapi Teaching and Research HospitalCompletedArthroscopic Shoulder Surgery | Suprascapular Nerve Block | Axillary Nerve BlockTurkey
-
Tanta UniversityRecruitingArthroscopic Shoulder Surgery | Anterior Suprascapular Nerve Block | Interscalene Nerve BlockEgypt
-
Bozyaka Training and Research HospitalCompletedPeripheral Nerve Block | Foot and Ankle Surgery | Popliteal Nerve BlockTurkey
-
Charite University, Berlin, GermanySuspendedAnesthesia, Local | Brachial Plexus Block | Nerve BlockGermany
-
Zagazig UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
-
University Hospital, AntwerpCompletedSurgery | Anesthesia | Brachial Plexus Block | Nerve BlockBelgium
-
Menoufia UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
-
Ondokuz Mayıs UniversityCompletedAnesthesia, Local | Brachial Plexus Block | Nerve BlockTurkey
-
Peking Union Medical College HospitalNot yet recruiting
Clinical Trials on Serratus Anterior Plane Block
-
Mansoura UniversityCompletedShoulder SurgeryEgypt
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingThoracic SurgeryUnited States
-
Kyungpook National University HospitalUnknownPain Management | ThoracotomyKorea, Republic of
-
Bezmialem Vakif UniversityRecruiting
-
Liu DiRecruitingLiver Neoplasms | Serratus Anterior Plane Block | Postoperative AnalgesiaChina
-
Cairo UniversitySamuel Bekhet Moawad; Ahmed Shaker Ragab; Michael Wahib WadidCompletedU/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve BlockEgypt
-
Ain Shams UniversityNot yet recruiting
-
National Cancer Institute, EgyptCompletedBreast Cancer | Postoperative PainEgypt
-
National Cancer Institute, EgyptRecruitingBreast Cancer | Acute Pain | Post-mastectomy Pain SyndromeEgypt
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingChronic Pain | Postoperative Pain | Acute Pain | Erector Spinae Plane Block | Serratus Anterior Plane Block | Video-Assisted Thoracoscopic SurgeryTurkey