Ultrasound Guided Serratus Plane Block Versus Thoracic Epidural for Post Thoracotomy Pain

NCT03933592 | Completed

• 1 other identifier: 201617026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at comparing the effect of serratus plane block versus thoracic epidural in patients undergoing thoracotomy for lung cancer surgery regarding pain control and possible side effects.

Conditions

Ultrasound Guided Serratus Plane Block; Thoracic Epidural; Post Thoracotomy Pain

Outcome Measures

Primary Outcomes (1)

• Score of postoperative pain at rest (Visual Analogue Scale, VAS, pain score).

  Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)

  24 hours postoperative

Secondary Outcomes (3)

• Score of postoperative pain at coughing (Visual Analogue Scale, VAS, pain score)

  24 hours postoperative

• Amount of postoperative opioid consumption

  24 hours postoperative

• No of patients developed adverse effects.

  24 hours postoperative

Study Arms (2)

Thoracic epidural

ACTIVE COMPARATOR

thoracic epidural inserted at low thoracic level in sitting position then test dose will be administered to detect any complications then a bolus of 10 ml of 0.25% levobupivacaine 30 mint before skin incision followed by an infusion of 5 ml/hour of 0.125% levobupivacaine after surgery.

Procedure: thoracic epidural

Serratus plane block

EXPERIMENTAL

after induction of anesthesia and Patients will be placed in the lateral position with the diseased side up. A linear ultrasound transducer (10-12 MHz) will be placed over the mid-axillary region of the thoracic cage in a sagittal plane. The rib will be counted inferiorly and laterally until the fifth rib is identified in the mid-axillary line. The following muscles will be identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). The needle (22- G, 50 - mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance a bolus of 30 ml of 0.25% levobupivacaine 30 min before skin incision. At the end of surgery, surgeon will put the catheter deep to serratus muscle and get it out with chest tube and fix it followed by an infusion of 5 ml/hour of 0.125% Levobupivacaine.

Procedure: Serratus anterior block

Interventions

Serratus anterior block PROCEDURE

after induction of anesthesia and Patients will be placed in the lateral position with the diseased side up. A linear ultrasound transducer (10-12 MHz) will be placed over the mid-axillary region of the thoracic cage in a sagittal plane. The rib will be counted inferiorly and laterally, until the fifth rib is identified in the mid-axillary line. The following muscles will be identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). The needle (22- G, 50 - mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance a bolus of 30 ml of 0.25% levobupivacaine 30 mint before skin incision. At the end of surgery, surgeon will put the catheter deep to serratus muscle and get it out with chest tube and fix it followed by an infusion of 5 ml/hour of 0.125% Levobupivacaine.

Serratus plane block

thoracic epidural PROCEDURE

In group I: thoracic epidural inserted at low thoracic level in sitting position then test dose will be administered to detect any complications then a bolus of 10 ml of 0.25% levobupivacaine 30 mint before skin incision followed by an infusion of 5 ml/hour of 0.125% levobupivacaine after surgery.

Thoracic epidural

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 20 to 60
• American Society of Anesthesiologists (ASA) physical status I-II grade
• Body mass index (BMI) \< 40 kg/m2
• Undergoing elective thoracic surgery.

You may not qualify if:

• Coagulation defects
• Refusal for serratus anterior block
• Inability to obtain informed consent
• Local infection at the site of injection
• Bone metastases
• Known allergy to any of the used drug

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute - Egypt

Cairo, Egypt

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 1, 2019
• Study Start: June 10, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 10, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)