Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03217292

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Analgesia following video-assisted thoracoscopic surgery (VATS) is important for the prevention of postoperative pulmonary complications.Various regional methods of anesthesia are currently being used to achieve this goal. The aim of the study was to assess the effectiveness of SAPB on postoperative VATS analgesia.

Condition or Disease	Intervention/Treatment	Phase
Nerve Block	Procedure: Serratus Anterior Plane Block Drug: IV patient-controlled analgesia (PCA) tramadol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, controlled, single-blindProspective, randomized, controlled, single-blind

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Effect of Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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.	Procedure: Serratus Anterior Plane Block Drug: IV patient-controlled analgesia (PCA) tramadol
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.	Drug: IV patient-controlled analgesia (PCA) tramadol

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.

Procedure: Serratus Anterior Plane Block

Drug: IV patient-controlled analgesia (PCA) tramadol

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.

Drug: IV patient-controlled analgesia (PCA) tramadol

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale [Postoperative 24 hours]
Visual Analogue Scale was used for pain

Secondary Outcome Measures

tramadol consumption [Postoperative 24 hour]
tramadol consumption
Ramsay sedation scale (RSS) [24 hours]
Ramsay sedation scale (RSS)

Other Outcome Measures

side effect profile [24 hours]
side effect profile
additional analgesic use [24 hours]
additional analgesic use

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

Principal Investigator: Burcu Metin Ökmen, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Korgün Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT03217292

Other Study ID Numbers:

2011-KAEK-25 2016/13-06

First Posted:

Jul 14, 2017

Last Update Posted:

Jul 17, 2017

Last Verified:

Jul 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tramadol

Study Results

No Results Posted as of Jul 17, 2017