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Ultrasound-Guided PEC I vs SAP Block for Postoperative Analgesia in Modified Radical Mastectomy (PECS I vs SAP)

A

Ain Shams University

Status

Completed

Conditions

Breast Cancer
Pectoral Nerve Blocks
Serratus Anterior Plane Block
Modified Radical Mastectomy

Treatments

Procedure: Ultrasound-Guided Pectoral Nerve Block (PECS I)
Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB)

Study type

Interventional

Funder types

Other

Identifiers

NCT07388238
MS 263/ 2021

Details and patient eligibility

About

This randomized double-blind controlled clinical trial was conducted to compare the analgesic efficacy of ultrasound-guided Pectoral Nerve Block versus Serratus Anterior Plane Block in female patients undergoing Modified Radical Mastectomy. Sixty-four ASA I-II female patients aged 35-60 years were randomly allocated into two equal groups: Group I received PEC I block and Group II received SAPB, using 20 ml of 0.25% bupivacaine in both groups after induction of general anesthesia.

Postoperative pain was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters, time to first rescue analgesia, total postoperative opioid consumption, and side effects were recorded. The SAPB group showed significantly lower postoperative pain scores during the first 6 hours, significantly longer time to first rescue analgesia, and significantly lower total pethidine consumption compared to the PEC I group. In addition, mean arterial blood pressure and heart rate were significantly lower intraoperatively and during early postoperative periods in the SAPB group. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group.

Conclusion: Ultrasound-guided Serratus Anterior Plane Block provides superior postoperative analgesia with better hemodynamic stability and fewer opioid-related side effects compared to Pectoral Nerve Block in patients undergoing Modified Radical Mastectomy

modified radical mastectomy

Full description

Postoperative pain following modified radical mastectomy (MRM) is often moderate to severe and may negatively affect patient recovery, increase opioid consumption, and contribute to postoperative complications such as nausea, vomiting, and hemodynamic instability. Regional analgesic techniques have become an integral component of multimodal analgesia strategies aiming to improve pain control while minimizing opioid-related adverse effects. Among these techniques, ultrasound-guided Pectoral Nerve Block (PEC I ) and Serratus Anterior Plane Block (SAPB) have gained increasing attention for breast surgeries. This randomized double-blind controlled clinical trial was designed to compare the efficacy of ultrasound-guided PEC I block versus ultrasound-guided SAPB for postoperative analgesia in female patients undergoing modified radical mastectomy under general anesthesia.

After obtaining approval from the Research Ethics Committee of the Faculty of Medicine, Ain Shams University, and written informed consent from all participants, a total of 64 female patients aged 35-60 years with ASA physical status I or II scheduled for MRM were enrolled. Patients were randomly allocated into two equal groups (32 patients each) using a computer-generated randomization sequence with sealed opaque envelopes to ensure allocation concealment. All patients received standardized general anesthesia. Following induction of anesthesia and under complete aseptic precautions, the assigned regional block was performed using ultrasound guidance. Patients in Group I received an ultrasound-guided PEC I block, where 20 ml of 0.25% bupivacaine was injected into the interpectoral plane between the pectoralis major and pectoralis minor muscles. Patients in Group II received an ultrasound-guided serratus anterior plane block, with 20 ml of 0.25% bupivacaine injected between the serratus anterior muscle and the external intercostal muscles. Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters including heart rate and mean arterial blood pressure were recorded intraoperatively and postoperatively at predefined intervals. The results demonstrated that SAPB provided superior postoperative analgesia compared to PEC I block. Patients in the SAPB group experienced significantly lower pain scores during the first 6 postoperative hours, a significantly longer time to first rescue analgesia, and a significant reduction in total postoperative pethidine consumption. Furthermore, the SAPB group showed better hemodynamic stability during intraoperative and early postoperative periods, with significantly lower heart rate and mean arterial blood pressure. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group. These findings suggest that ultrasound-guided serratus anterior plane block is a more effective and safer regional analgesic technique than pectoral nerve block for postoperative pain management in patients undergoing modified radical mastectomy, offering improved analgesia, reduced opioid requirements, and fewer adverse effects.

Enrollment

32 patients

Sex

Female

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Physical status: ASA grades I and II
  • Age between 35 and 60.

Exclusion Criteria

  • Known Allergy to one of the study drugs.
  • Pregnant patients.
  • Other Malignancy.
  • History or evidence of coagulopathy, use of anti coagulant or anti platelet therapy

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

Ultrasound-Guided Pectoral Nerve Block (PECS I) Arm
Experimental group
Description:
Participants in this arm receive an ultrasound-guided pectoral nerve block (PECS I) after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected into the interpectoral plane between the pectoralis major and pectoralis minor muscles for postoperative analgesia following modified radical mastectomy.
Treatment:
Procedure: Ultrasound-Guided Pectoral Nerve Block (PECS I)
Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Arm
Experimental group
Description:
Participants in this arm receive an ultrasound-guided serratus anterior plane block after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected between the serratus anterior muscle and the external intercostal muscles for postoperative analgesia following modified radical mastectomy.
Treatment:
Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB)

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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