Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy
Condition: Modified Radical Mastectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Erector spinae plane block (ESPB) is a new evolving fascial pain block in the era of regional
      anaesthesia. ESPB was applied in varieties of surgeries and provided an eminent role in
      trauma patient especially those with fracture ribs. ESPB exhibits simple, safe and easy
      technique with minimal or no sympathetic blockade effects, thus gaining popularity in wide
      range of surgeries. The optimum effective dose of local anaesthetic, the effective volume of
      drug used for desired dermatomes. Comparison with different regional blocks is preferable to
      know the optimum analgesic technique for those population of patients (4). Many studies have
      already compared solo ESPB with thoracic epidural analgesia (TEA), thoracic paravertebral
      block (TPVB), serratus anterior plane block (SAPB) and pectoral nerves block. Only few case
      reports described the combination effect of rhomboid intercostal, transversus thoracic muscle
      and parasternal plane blocks to ESPB in modified radical mastectomy.
    

Detailed description: 
      patients scheduled for modified radical mastectomy and axillary dissection under general
      anesthesia (GA) will be included in the study. The patients will be randomly allocated by a
      computer-generated table into one of the two study groups.Thoracic paravertebral block group
      (TPV group) and combined erector spinae and pecto-intercostal fascial plane blocks group
      (ES-PI group).

      0.25% bupivacaine and 1 mg dexamethasone will be injected with different volumes in each
      block.

      The first time to ask for rescue analgesia post-operatively will be measured. Using MedCalc
      Software version 14 (MedCalc Software bvba, Ostend, Belgium), 24 patients (12 patients per
      group) were calculated for a relative difference of 10% (0.635 hours) in the time to first
      analgesic request between both groups, with a study power of 95% and an alpha error of 0.05.
      This number will be increased to 30 patients (15 patients per group) to compensate for
      possible dropouts.

      Analysis of data will be performed using the Statistical Package for Social Science (SPSS)
      software, version 21 for Microsoft Windows (SPSS Inc., Chicago, iL, USA). Categorical data
      will be reported as numbers and percentages and will be analyzed using the chi-squared test.
      Continuous data will be checked for normality using the Kolmogorov-Smirnov test. Normally
      distributed data will be presented as means (standard deviations) and will be analyzed using
      the unpaired student t-test. Skewed data will be expressed as medians(quartiles) and will be
      analyzed using the Mann Whitney U test. For repeated measures, a two-way repeated measures
      ANOVA will be used to evaluate block (between-groups factor) and time (repeated measures)".
      Post-hoc pairwise comparison will be performed using the Bonferroni test. A P value of 0.05
      or less will be considered significant.
    

Intervention name(s): Bupivacaine Hydrochloride; Dexamethasone phosphate
Intervention type(s): Drug; Drug
Intervention description(s): We hypothesize that combined ESPB and PIPB are as effective as TPVB in controlling perioperative pain in patients undergoing modified radical mastectomy (MRM) with lesser complications using bupivacaine hydrocloride; used as additive to bupivacaine
Other intervention name(s): marcaine; decadrone
Intervention MeSH terms: Dexamethasone; Bupivacaine; Dexamethasone 21-phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The effectiveness of combined ultrasound guided erector spinae and pectointercostal fascial plane blocks versus ultrasound guided thoracic paravertebral block in controlling perioperative pain in modified radical mastectomy, a blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment