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Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy

ConditionsCostotransverse Foramen BlockErector Spinae Plane BlockModified Radical Mastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNational Cancer Institute, Egypt

About this trial

This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult females > 18 years and ≤ 65 years old.

American Society of Anesthesiologists (ASA) physical status П-III.

Body mass index (BMI) 18-35 kg/m2.

Scheduled for modified radical mastectomy.

Disqualifiers

Known allergy or hypersensitivity to local anesthetic agents.

Active infection at the injection site (e.g., cellulitis, abscess).

Coagulopathy or ongoing anticoagulant/antiplatelet therapy [International Normalized Ratio (INR) > 1.5 or platelet count < 100,000/µL].

Severe respiratory, cardiac, hepatic, or renal disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Costotransverse foramen block

    Other intervention

    Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.

  • Erector spinae plane block

    Other intervention

    Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: CTFB GroupExperimental treatment 1 intervention
Group B: ESPB GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total morphine consumption

If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.

Time frame
24 hours postoperatively

Secondary outcomes

1

Degree of pain

Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS score will be recorded in post-anesthesia care unit (PACU) then at 1, 6, 12, 18, 24, and 48 hours postoperatively.

Time frame
48 hours postoperatively
2

Time to first request of rescue analgesia

Time to first request of rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

Time frame
24 hours postoperatively
3

Intraoperative fentanyl consumption

Intraoperative fentanyl consumption will be recorded.

Time frame
Intraoperatively
4

Mean arterial pressure

Mean arterial pressure will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.

Time frame
4 hours postoperatively

Other outcomes

Sponsors and contacts

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National Cancer Institute, Egypt

Lead sponsor

Source ClinicalTrials.gov
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