US-Guided Serratus Anterior Plane Block Versus Thoracic Epidural in Patients Undergoing Thoracotomy
Efficacy of Perioperative US-Guided Serratus Anterior Plane Block Versus Thoracic Epidural in Adult Patient Undergoing Thoracotomy: A Randomized Comparative Double-Blinded Trial
1 other identifier
interventional
74
1 country
1
Brief Summary
Thoracic surgeries is known to be one of the most painful surgeries . Multiple analgesic techniques have been used for post operative analgesia including Thoracic epidural , Patient Controlled Analgesia and systemic opioids. Opioids are associated with multiple sied effects including : PONV , Respiratory depression and ileus while thoracic epidural has its own complications such as hemodynamic instability , injury of spinal cord, pneumothorax and epidural hematoma. Peripheral nerve blocks provide good alternative for perioperative analgesia. The purpose of our study is to compare the effectiveness of perioperative continuous serratus anterior plane block versus continuous thoracic epidural in pain management during thoracic surgeries for malignancy resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Jun 2021
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 3, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2023
CompletedJanuary 5, 2023
January 1, 2021
8 months
January 3, 2023
January 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative total morphine requirement.
Postoperative total morphine requirement.
24 hours
Secondary Outcomes (5)
Intraoperative fentanyl requirement.
300 minutes
Time to the first analgesia requested by the patient.
24 hours
Postoperative pain
24 hours
Length of hospital stay.
2 weeks
Patient satisfactory score
24 hours
Study Arms (2)
Serratus anterior plane block:
EXPERIMENTALThoracic Epidural
ACTIVE COMPARATORInterventions
in lateral position a linear transducer (10-12MHz, M-Turbo) will be used, The 5th rib is identified in the mid-axillary line. The following muscles are overlying the rib latissimusdorsi ,teres major, and serratus muscle.The needle (22G, 50-mm Tuohy needle) is introduced in-plane targeting the plane superficial to serratus muscle. local anesthetic is injected then a catheter is threaded and . Ultrasound-guided SAPB was done using a serratus anterior catheter Group DL (n=20) received a bolus of 30 mL of 0.25% bupivacaine followed by a continuous infusion of 0.125% bupivacaine at a rate of 7-12 ml/hr according to patient response upon ICU arrival after the stabilization of the clinical status. The infusion was continued until the end of the 1st 24 hours postoperatively .
A thoracic epidural catheter was done to the patient while sitting. Tuohy needles are used. Epidural space can be identified by loss of resistance. Injection begins with a negative aspiration and a test dose (3 ccs of 1.5% lidocaine with 1:200,000 epinephrine) .A Continuous epidural technique through the placement of a catheter 3-5 cm beyond the needle is applied. Injection in 5ml increments of 0.25% bupivacaine is used until the block of the required segments achieved ( 10 to 15ml). sensory testing is via pinprick and cold test to detect sympathetic block . Throughout the technique hourly injection of 5 ml 0.25% bupivacaine for maintenance.
Eligibility Criteria
You may qualify if:
- Physical status ASA II and III.
- Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.
- A patient undergoing thoracotomy for cancer surgery (Lobectomy, Pneumonectomy, and Decortication).
You may not qualify if:
- Patient refusal
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders.
- Localized infection at the site of block.
- Coagulopathies with a platelet count below 50,000 or an INR\>1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities \& deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency \&therapeutic anticoagulants drugs),History of unexplained or easy bruising and Prolonged bleeding from small cuts or after dental procedures.
- patients need prolonged mechanical ventilation postoperatively excluded from our study.
- failed blocks will be excluded from our study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ashgan R Ali, Professor
Anaesthesiology Faculty of Medicine - Cairo University
- STUDY DIRECTOR
Heba I Ahmed, Ass. Professor
Anaesthesiology Faculty of Medicine - Cairo University
- STUDY DIRECTOR
Reham M Gamal, Lecturer
Anaesthesiology National Cancer Institute - Cairo University
- PRINCIPAL INVESTIGATOR
Sylvia Samy Bassily Morgan, Master
Anaesthesiology National Cancer Institute - Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2023
First Posted
January 5, 2023
Study Start
June 1, 2021
Primary Completion
February 1, 2022
Study Completion
March 1, 2022
Last Updated
January 5, 2023
Record last verified: 2021-01