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The Pectoralis (PECS2) Block Versus Intrathecal Morphine

Primary Purpose

Post-operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intrathecal morphine injection
ultrasound guided PECS2 block
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-operative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sohag UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Morphine group (n= 25):

PECS group (n= 25):

Arm Description

Outcomes

Primary Outcome Measures

post-operative analgesia.
the visual analog score will be evaluated postoperatively in all the patients in both groups

Secondary Outcome Measures

Full Information

First Posted
April 29, 2023
Last Updated
September 8, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT06016205
Brief Title
The Pectoralis (PECS2) Block Versus Intrathecal Morphine
Official Title
Ultrasound-guided PECS2 (The Pectoralis) Block Versus Intrathecal Morphine for Postoperative Analgesia After Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine group (n= 25):
Arm Type
Active Comparator
Arm Title
PECS group (n= 25):
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
intrathecal morphine injection
Intervention Description
Patients will receive intrathecal 200 microgram morphine immediately before induction of general anesthesia
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided PECS2 block
Intervention Description
ultrasound guided PECS2 block will be performed with 30 ml bupivacaine 0.25%
Primary Outcome Measure Information:
Title
post-operative analgesia.
Description
the visual analog score will be evaluated postoperatively in all the patients in both groups
Time Frame
he visual analog score will be evaluated every 1 hour postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Ahmed Mahmoud, MD
Phone
01091328413
Ext
002
Email
mohamedmahmoud@med.sohag.edu.eg
Facility Information:
Facility Name
Sohag University
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Ahmed Mahmoud, MD
Phone
01091328413
Ext
002
Email
mohamedmahmoud@med.sohag.edu.eg

12. IPD Sharing Statement

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The Pectoralis (PECS2) Block Versus Intrathecal Morphine

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