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Post-operative PainNCT06016205

The Pectoralis (PECS2) Block Versus Intrathecal Morphine

A study testing intrathecal morphine injection and ultrasound guided PECS2 block in people with Post-operative Pain, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Post-operative Pain
What is being tested?
intrathecal morphine injection and ultrasound guided PECS2 block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • - 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

Trial locations and contacts

1 site in 1 country.

Mohammed Ahmed Mahmoud, MD contact

01091328413 ext. 002

mohamedmahmoud@med.sohag.edu.eg

Egypt1 site, 1 recruiting
  • Sohag University

    Sohag

    Mohammed Ahmed Mahmoud, MD, 01091328413 ext. 002, mohamedmahmoud@med.sohag.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.
Being tested
intrathecal morphine injection, ultrasound guided PECS2 block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intrathecal morphine injectionProcedure or surgery

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

  • ultrasound guided PECS2 blockProcedure or surgery

    ultrasound guided PECS2 block will be performed with 30 ml bupivacaine 0.25%

Study groups in NCT06016205
Study groupRoleWhat they receive
Morphine group (n= 25):Active comparatorNot described
Receives: Procedure: intrathecal morphine injection
PECS group (n= 25):Active comparatorNot described
Receives: Procedure: ultrasound guided PECS2 block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. post-operative analgesia.

    the visual analog score will be evaluated postoperatively in all the patients in both groups

    Measured: he visual analog score will be evaluated every 1 hour postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06016205
Sponsor's protocol ID
Soh-Med-22-07-33
Status last verified
Sep 2023
First submitted
29 Apr 2023
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing intrathecal morphine injection and ultrasound guided PECS2 block in people with Post-operative Pain, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohammed Ahmed Mahmoud, MD (01091328413 ext. 002, mohamedmahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post-operative analgesia. (time frame: he visual analog score will be evaluated every 1 hour postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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