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NCT Number: NCT06873893

Comparing Between 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

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams university

Cairo , Abbassya, Egypt

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 )

Treatment and study plan

Midpoint transverse process block

Procedure

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 block

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. -Number of patients requested rescue analgesia

    Time frame: 18 hour postoperative

  2. The total number of doses of rescue analgesia

    Time frame: 18 hours postoperatively

    -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

  3. Incidence of complications

    Time frame: 18 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

yasmin tarek elshahawy, assistant lecturer

CONTACT

[email protected]

00201150009799

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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