The Pectoralis (PECS2) Block Versus Intrathecal Morphine

Ultrasound-guided PECS2 (The Pectoralis) Block Versus Intrathecal Morphine for Postoperative Analgesia After Mastectomy

50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery, Will be included in the study.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain
• Intervention / Treatment: Procedure: intrathecal morphine injection; Procedure: ultrasound guided PECS2 block

Detailed Description

Patients will be randomly divided into two groups:

morphine group (n=25):

Patients will receive intrathecal 200 microgram morphine immediately before induction of general anesthesia.

PECS group (n= 25):

PECS2 block will be performed and Patients will receive 30 ml bupivacaine 0.25% The drug solutions will be prepared by an anesthesiologist not involved in the study, the anesthesiologist performing the block and observing the patients will be blinded to the treatment group. Data collection will be done by anesthesiologist unaware of the group allocation.

In the PECS group patients will be placed in supine position. The block will be performed on the side of surgery with the ipsilateral upper limb in abduction position. After the skin of the infraclavicular region disinfected and preparing the US probe and adjusting the depth of 4 to 6cm and gain of Ultrasound machine .The 20-gauge echogenic needle will be introduced in-plane approach from medial to lateral and 10ml of bupivacaine 0.25% will be injected into the fascial plane between pectoralis muscles in order to block medial and lateral pectoral nerve (PECS I). Then the needle will be reinserted into the fascial plane between pectoralis minor and serratus anterior muscle and 20ml of bupivacaine 0.25%will be injected in increments of 5 ml after negative aspiration in order to block intercostals II-III-IV-V-VI and the long thoracic nerve.

General anesthesia will be induced in all patients with fentanyl (1-2ug/kg), propofol (1-2mg/kg) and an intuitive dose of atracurium (0. 5mg/kg), endotracheal intubation secured the airway. Anesthesia will be maintained with isoflurane (1- 2%) and an incremental dose of atracurium 0.1mg/kg. Controlled ventilation will be accomplished by a ventilator with a tidal volume of 6-8 ml/kg and an I/E ratio of 1:2 to maintain a tidal carbon dioxide voltage of approximately 35-40 mmHg.

The heart rate (HR), noninvasive arterial systolic blood pressure (SBP), diastolic blood pressure (DBP) and peripheral oxygen saturation (SpO2) will be recorded at baseline, after induction and with skin incision and every 5 minutes intraoperative till the end of surgery. And postoperative at 30 min, 1, 2, 3, 6, 12 and 24 hours.

- Postoperative pain will be assessed using visual analog score (VAS) [0-10]. 0 - 3 mild pain

• 4 - 6 moderate pain
• 7 - 10 severe pain
• 10 <unbearable pain)

All patients will receive paracetamol (1gm) immediately postoperative and every 6 hours. Patients will be assessed every one hour in the first 6 hours then every 4 hours in the next 18 hours. Patients will receive ketorolac 30 mg if VAS 3-5. If VAS>5, morphine 0.1mg/kg will be given then total ketorolac and morphine consumption in 24 hours will be calculated and compared between both groups.

Adverse effects will be considered as -bradycardia (if heart rate [HR] is <20% of baseline) will be treated by atropine (IV) 0.01 mg/kg.

• Hypotension (if mean arterial blood pressure is <20% of baseline) will be treated with (IV) fluid and an incremental (IV) dose of ephedrine 0.2- 0.3 mg/kg or (SC/IM) dose of ephedrine 0.5 mg/kg.
• Respiratory depression, apnea and hypoxemia (spo2 < 92%) will be treated with O2 supplementation.
• Also, complications as disturbed conscious level, nausea, vomiting and prolonged motor block will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed Ahmed Mahmoud, MD; Phone Number: 002 01091328413; Email: mohamedmahmoud@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University
    • Contact: Mohammed Ahmed Mahmoud, MD; Phone Number: 002 01091328413; Email: mohamedmahmoud@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery.

Exclusion Criteria:

• - Patient refusal.
• Patient with significant neurological , psychiatric or neuromuscular disease
• Alcoholism. Drug abuse.
• Pregnancy or lactating women.
• Suspected Coagulopathy.
• Morbid obesity.
• Known allergy to study medications.
• local infection at the block site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morphine group (n= 25):	Procedure: intrathecal morphine injection; Patients will receive intrathecal 200 microgram morphine immediately before induction of general anesthesia
Active Comparator: PECS group (n= 25):	Procedure: ultrasound guided PECS2 block; ultrasound guided PECS2 block will be performed with 30 ml bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative analgesia.	the visual analog score will be evaluated postoperatively in all the patients in both groups	he visual analog score will be evaluated every 1 hour postoperatively.

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 29, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: Soh-Med-22-07-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No