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

NCT03217292 | Completed

• 1 other identifier: 2011-KAEK-25 2016/13-06
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  Visual Analogue Scale was used for pain

  Postoperative 24 hours

Secondary Outcomes (2)

• tramadol consumption

  Postoperative 24 hour

• Ramsay sedation scale (RSS)

  24 hours

Other Outcomes (2)

• side effect profile

  24 hours

• additional analgesic use

  24 hours

Study Arms (2)

Group S

EXPERIMENTAL

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

Group T

ACTIVE COMPARATOR

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

Interventions

Serratus Anterior Plane Block PROCEDURE

Group S

IV patient-controlled analgesia (PCA) tramadol DRUG

Group S; Group T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).

You may not qualify if:

• Previous history of opioid use preoperatively,
• Allergy to local anesthetics,
• The presence of any systemic infection,
• Uncontrolled arterial hypertension,
• Uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

MeSH Terms

Interventions

Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Tramadol

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Burcu Metin Ökmen

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, controlled, single-blind

Study Record Dates

• First Submitted: July 2, 2017
• First Posted: July 14, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 17, 2017

Record last verified: 2017-07