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

NCT ID: NCT03217292

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2016-12-01

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.

Conditions

Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Serratus Anterior Plane Block

Intervention Type: PROCEDURE

IV patient-controlled analgesia (PCA) tramadol

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

IV patient-controlled analgesia (PCA) tramadol

Intervention Type: DRUG

Interventions

Serratus Anterior Plane Block

Intervention Type: PROCEDURE

IV patient-controlled analgesia (PCA) tramadol

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Korgün Ökmen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcu Metin Ökmen

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Other Identifiers

2011-KAEK-25 2016/13-06

Identifier Type: -

Identifier Source: org_study_id