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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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
- Conditions
- Post Operative Pain
- 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 group | Role | What they receive |
|---|---|---|
| pectoral nerve block group | Active comparator | 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 Receives: Procedure: Pectoral Nerve Block |
| Mid-point transverse process block group | Active comparator | 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 ) Receives: Procedure: Midpoint transverse process block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
-Number of patients requested rescue analgesia
Measured: 18 hour postoperative
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
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.
- First posted13 Mar 2025
- Study start1 Jul 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin tarek ali ahmed elshahawy, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06873893
- Acronym / sponsor ID
- FMASU MD11/2024
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pectoral nerve block group | Active comparator | Procedure: Pectoral Nerve BlockThis 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 |
| Mid-point transverse process block group | Active comparator | Procedure: Midpoint transverse process blockThis 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 ) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all female patients undergoing modified radical mastectomy
- age between 35 to 65
Key exclusion criteria (5 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midpoint transverse process blockThis 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 ) | Procedure or surgery | Mid-point transverse process block group |
| Pectoral Nerve BlockThis 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 | Procedure or surgery | pectoral nerve block group |
Primary outcome
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
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)
3 secondary outcomes
-Number of patients requested rescue analgesia
Time frame: 18 hour postoperative
The total number of doses of rescue analgesia
Time frame: 18 hours postoperatively
Incidence of complications
Time frame: 18 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.