Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNational Cancer Institute, Egypt

About this trial

The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients age ≥ 18 years and ≤ 65 Years.

Type of surgery; Modified Radical Mastectomy (MRM)

Physical status ASA II, III.

Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Disqualifiers

Patient refusal.

Allergy or a contraindication to the drug used in the study, e.g. local anesthetics, opioids.

History of psychological disorders.

History of chronic pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector spinae plane block (ESPB)

    Drug

    Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We will inject 15ml at the level of T2 and 15ml at the level of T5.

  • Thoracic epidural block

    Drug

    Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Erector spinae plane block (ESPB)Experimental treatment 1 intervention
Group B: Thoracic epidural blockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The average duration of analgesia

The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.

Time frame
24 hours postoperatively

Secondary outcomes

1

The total amount of morphine

Patient will be discharged to the ward then rescue analgesia will be given in the form of IV morphine 3 mg boluses if the patient reported Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups.

Time frame
24 hours postoperatively
2

Incidence of postmastectomy pain syndrome

Incidence of postmastectomy pain syndrome at 1, 3, and 6 months postoperatively will be recorded.

Time frame
6 months postoperatively
3

The total amount of fentanyl

Fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of the baseline levels.

Time frame
Intraoperatively
4

Heart rate (HR)

Heart rate will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively

Time frame
24 hours Postoperatively

Other outcomes

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