Comparison Between Erector Spinae Plane Block Versus Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorKholoud Usama

About this trial

The goal of this clinical trial is to compare Ultrasound Guided Erector Spinae and Ultrasound Guided Serratus Anterior Plane Block post Modified Radical Mastectomy in adult females. the main questions it aims to answer are:

* Which of the two blocks has a better analgesic effect? * Which of the two blocks is safer as regards inducing a pneumothorax and affecting the hemodynamics?

Participants:

* Will be divided into two groups after signing the informed consent. * After being anesthetized and before surgical incision; the blocks will be given to the patient. * Lung Ultrasound will be done for each patient to rule out pnemothorax once before the surgery and another after the end of surgery while the patient is being anesthetized. * Patients that will experience pneuomothorax will be excluded from the study, and will be treated according to its size. * Follow up of the patient for 24 hours postoperative to record the VAS score continuously, with giving increments of pethidine intravenously to relief pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA Physical Status II, or III.

Age 21 - 65 years.

Female gender

Disqualifiers

ASA IV, V, VI.

Infection at site of block.

Coagulopathy, or patients on antiplatelets, or anticoagulants.

Previous anesthetic allergy to bupivacaine.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Unilateral Erector Spinae group

    Procedure/Surgery

    On injecting 30 ml of bupivacaine 0.25% with 20 mcg Dexamedetomidine into the interfacial plane below erector spinae; a manifest linear pattern will be visualized uplifting the muscle.

  • Unilateral Serratus Anterior group

    Procedure/Surgery

    Once the needle will be in perfect position, confirmed by hydro-dissection on injecting 2-3 ml of normal saline, then 30 ml of bupivacaine 0.25% with 20 mcg Dexamedetomidine.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Unilateral Erector Spinae groupActive comparator 1 intervention
Group B: Unilateral Serratus Anterior groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Score for pain

* After extubation, the patient will be discharged from the operating room. VAS will be used to assess the postoperative pain (Myles et al., 2017). * Visual analogue scale score: Grade 0 (0-1 units on a scale): Good analgesia. Grade I (2-4 units on a scale): Moderate analgesia Grade II (5-7 units on a scale): Mild analgesia Grade III (8-10 units on a scale): No analgesia. * If VAS \>3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given. * VAS ranging from (0 units on a scale) no pain, to (10 units on a scale) severe intolerable pain;

Time frame
at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively

Secondary outcomes

1

Total dose of pethidine in mg.

If VAS \>3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given.

Time frame
at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
2

Duration of analgesia postoperatively in hours.

If VAS \>3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given.

Time frame
at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
3

Rate of vital data changes over the postoperative period

HR and MBP will be measured upon arrival to the PACU and after 30 min, then every hour if the patients remain in the PACU. In the surgical ward, vital signs (HR, SBP, MBP, DBP) as well as pain intensity will be assessed every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.

Time frame
every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.
4

Incidence of pneumothorax

* Measurement tool: Lung ultrasound * After giving the block in each group, Lung Ultrasound will be performed on patients in the supine body position. The transducer will be placed longitudinally at the highest point of the anterior thorax, then moved along the intercotal spaces of the parasternal line and laterally, between the anterior and posterior axillary line, checking for lung sliding and lung point in 2D B-mode, and for seashore or stratosphere sign in M-mode. The hemithorax without intervention was examined first and then compared to the hemithorax with intervention. * The Lung Ultrasound will be repeated after the end of the surgery, while the patient is anesthetized, and before extubation. Cases of pneumothoraces either large or small will be excluded from the study.

Time frame
Intra-operatively

Other outcomes

Sponsors and contacts

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Kholoud Usama

Lead sponsor

Ain Shams University

Sponsor institution