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Post Operative PainNCT06873893

Comparing Between Ultrasound Guided Pectoral Nerve Block Versus Ultrasound Guided Mid-point Transverse Process Block for Postoperative Analgesia in Patients Undergoing Modified Radical Mastectomy

A study testing Midpoint transverse process block and Pectoral Nerve Block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to compare the effectiveness of ultrasound guided pectoral nerve block versus mid-point transverse process block for postoperative analgesia in patients undergoing modified radical mastectomy Read more about this study

Who is it for?
Ages 35 to 65 years, women only
Conditions the study is for
Post Operative Pain
What is being tested?
Midpoint transverse process block and Pectoral Nerve Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jul 2024to Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • all female patients undergoing modified radical mastectomy
  • age between 35 to 65

Who cannot join

  • patient refusal of procedure or participation in the study
  • duration of operation more than 180 minutes
  • known ASA IV or more
  • local skin infection at site of the block
  • contraindication of local anesthetic infiltration ( history or evidence of coagulopathy , use of anticoagulant or antiplatelet therapy , known allergy of local anethestic (bupivacaine )

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

yasmin tarek elshahawy, assistant lecturer contact

00201150009799

Yasminelshahawy@med.asu.edu.eg

Egypt1 site, 1 recruiting
  • Ainshams university

    Cairo , Abbassya

    Recruiting

Other trials in Egypt

About this study

Official title: Efficacy of Ultrasound Guided Pectoral Nerve Block Versus Ultrasound Guided Mid-point Transverse Process Block for Postoperative Analgesia in Patients Undergoing Modified Radical Mastectomy

The aim of the study is to compare the effectiveness of ultrasound guided pectoral nerve block versus mid-point transverse process block for postoperative analgesia in patients undergoing modified radical mastectomy

Read the detailed description

preoperative assessment will be done for every patient including history, clinical examination \&laboratory investigation ( coagulation profile ) according to age , physical state . all patients will be instructed about numeric rating scale of pain (NRS) , intravenous access will be placed under complete aseptic condition . on arriving to operating room , standard ASA monitoring ( ECG , non invasive arterial blood pressure and pulse oximetry ) will be assembled. baseline readings of all vital data will be recorded before induction , induction of anesthesia will be done by propofol 2mg/kg , atracurium 0.5mg/kg and fentanyl 1mcg/kg . endotracheal intubation will be placed then patients will be mechanically ventilated with setting keeping end tidal CO2 between 35-45 mmHg . anesthesia will be maintained with volatile anesthetic (isoflurane) and atracurium 0.1mg/kg every 20 minutes, maintenance fluid will be given according to patient's weight , fasting hours , and duration of surgery . incremental doses of fentanyl ( 1mcg/kg ) will be given every 2 hours according to duration of surgery . all patients will receive 1gm parecetamol with skin closure .

both blocks will be done by an experienced anesthesiologist in sonar guided peripheral nerve blockade under complete aseptic conditions, after induction of general anesthesia .

patients will be randomly divided into two groups P-Group : pectoral nerve block patient will be positioned in supine position and patient's arm next to the body , the linear probe (10-12 MHz) will be positioned in the parasagittal plane below the lateral half of the clavicle . the pectoral branch of the thoraco-acromial artery will be identified between pectoralis major and minor using color doppler. in-plane needle approach will be used , and the needle will be advanced from medial to lateral direction enter the plane between pectoralis major and pectoralis minor , a volume of 10ml of bupivacaine 0.5% will be injected between the two muscles (the interpectoral plane ) with careful intermitted aspiration to avoid intravascular injection . Then the needle will be advanced into the plane between te pectoralis minor and serratus muscles , and 10ml of bupivacaine will be injected watching for the spread between two muscles under ultrasound guidance with careful intermitted aspiration to avoid intravascular injection M-Group : mid-point transverse process block in the lateral position , the T4 spine will be counted by ultrasound and high frequency linear probe (10-12MHz) will be placed longitudinally , approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction , the desired end point for the needle tip will be the midpoint of the line between the posterior border of transverse process of T4 and the pleura (injection will be deep to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment) the needle tip does not enter the paravertebral space , a volume of titrated bolus of 20ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection, pleural displacement and bowing of erector spinae will be observed at the side of injection

Being tested
Midpoint transverse process block, Pectoral Nerve 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.

  • Midpoint transverse process blockProcedure or surgery

    This group will receive a volume of 20ml of bupivacaine 0.5% at midpoint of the line between the posterior border of the transverse process of T4 and the pleura ( injection will be deep to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligament )

  • Pectoral Nerve BlockProcedure or surgery

    This group will receive a volume of 10ml of bupivacaine 0.5% will be injected between the pectoralis major and pectoralis minor muscle then another 10ml bupivacaine will be injected between pectoralis minor and serratus anterior muscle

Study groups in NCT06873893
Study groupRoleWhat they receive
pectoral nerve block groupActive comparatorThis group will receive a volume of 10ml of bupivacaine 0.5% will be injected between the pectoralis major and pectoralis minor muscle then another 10ml bupivacaine will be injected between pectoralis minor and serratus anterior muscle
Receives: Procedure: Pectoral Nerve Block
Mid-point transverse process block groupActive comparatorThis group will receive a volume of 20ml of bupivacaine 0.5% at midpoint of the line between the posterior border of the transverse process of T4 and the pleura ( injection will be deep to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligament )
Receives: Procedure: Midpoint transverse process block

What is being measured

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

  1. the time to first rescue analgesia for every patient

    when the patients with numeric rating scale 4 or more will receive 5mg morphine IV as rescue analgesia (the higher numeric rate score means a worse outcome)

    Measured: Up to 18 hours after surgery , time between end of operation and when patients ask for rescue analgesia with NRS 4 or more

Secondary outcomes (3)
  1. -Number of patients requested rescue analgesia

    Measured: 18 hour postoperative

  2. The total number of doses of rescue analgesia

    -the total number of doses of rescue analgesia that will be administered in the 18 hours postoperatively if the NRS pain score at rest 4 or more

    Measured: 18 hours postoperatively

  3. Incidence of complications

    Measured: 18 hours postoperatively

Timeline

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

  1. First posted13 Mar 2025
  2. Study start1 Jul 2024
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873893
Sponsor's protocol ID
FMASU MD11/2024
Status last verified
Feb 2025
First submitted
16 Feb 2025
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Midpoint transverse process block and Pectoral Nerve Block in people with Post Operative Pain, run by Ain Shams 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact yasmin tarek elshahawy, assistant lecturer (00201150009799, Yasminelshahawy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the time to first rescue analgesia for every patient (time frame: Up to 18 hours after surgery , time between end of operation and when patients ask for rescue analgesia with NRS 4 or more). 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 Mar 2025.

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