Single Path Versus Double Path PECS I and II Blocks as an Efficient Analgesic Choice in Female Breast Surgeries.
Condition: Analgesia
Study type: Interventional

Summary: 
      The patients are allocated by computer generated random number method into 2 groups: single
      needle path PECS I and II block group, where patients receive induction with pec I and II
      blocks which are performed under ultrasound guidance , with a linear ultrasound transducer on
      the same side of surgery. The patients are placed in the supine position where the elbow was
      flexed and shoulder will be abducted. The probe is placed inferior to the clavicle . A linear
      probe and a beveled tip needle will be introduced with an in-plane technique . The US probe
      is initially placed below outer third of the clavicle after skin sterilization showing
      pectoralis major and minor muscles and the thoraco- acromial artery then moved
      infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles are
      visualised . The US probe is then moved toward anterior axillary line till pectoralis minor
      and serratus anterior muscles are identified at 4th rib at the level of thoraco-acromial
      artery then the needle is inserted in plane with the probe from caudal to cranial using an
      inclined manner, 15mL of bupivacaine will be put into the potential space between pectoralis
      minor muscle and serratus muscle (PECS II) then it will be withdrawn to inject another 15 ml
      of bupivacaine in the plane between pectoralis muscles . The block will be performed with
      needle introduced in-plane with the ultrasound probe, and the local anesthetic (LA) injection
      is visualized .

      In double needle path PECS I and II block group The probe is initially placed below outer
      third of the clavicle after skin sterilization showing pectoralis major and minor muscles and
      the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis
      major and pectoralis minor muscles are visualised, then the needle is inserted in plane with
      the probe and 15mL of bupivacaine is put into the potential space between pectoralis muscles.
      In the second puncture , the probe is moved toward anterior axillary line till pectoralis
      minor and serratus anterior muscles will be identified at 4th rib at the level of
      thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal
      to cranial , 15mL of bupivacaine is put into the potential space between pectoralis minor
      muscle and serratus muscle (PECS II).
    

Detailed description: 
      The patients will be randomly allocated by computer generated random number method into 2
      groups: single needle path PECS I and II block group(n = 30) where patients will receive
      induction with pec I and II blocks which will be performed under ultrasound guidance
      (S-Nerve; Sono-Site Iberica S.L, Madrid, Spain), with a linear ultrasound transducer(10-12
      MHz) on the same side of surgery. The patients will be placed in the supine position where
      the elbow was flexed and shoulder will be abducted. The probe will be placed inferior to the
      clavicle . A linear probe and a beveled tip needle will be introduced with an in-plane
      technique . The US probe will be initially placed below outer third of the clavicle after
      skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial
      artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis
      minor muscles will be visualised . The US probe was then moved toward anterior axillary line
      till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the
      level of thoraco-acromial artery then the needle will be inserted in plane with the probe
      from caudal to cranial using an inclined manner, 15mL of bupivacaine 0.25% after negative
      aspiration will be put into the potential space between pectoralis minor muscle and serratus
      muscle (PECS II) then it will be withdrawn to inject another 15 ml of bupivacaine 0.25% in
      the fascial plane between pectoralis muscles . The block will be performed with needle (22-G,
      80-mm (SonoTap, Pajunk, Geisingen, Germany) introduced in-plane with the ultrasound probe,
      and the local anesthetic (LA) injection will be visualized in real-time .

      In double needle path PECS I and II block group (n = 30) The US probe will be initially
      placed below outer third of the clavicle after skin sterilization showing pectoralis major
      and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate
      fourth rib where pectoralis major and pectoralis minor muscles will be visualised, then the
      needle will be inserted in plane with the probe and 15mL of bupivacaine 0.25% after negative
      aspiration will be put into the potential space between pectoralis muscles. In the second
      puncture , the US probe will be moved toward anterior axillary line till pectoralis minor and
      serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial
      artery then the needle will be inserted in plane with the probe from caudal to cranial in an
      inclined way, 15mL of bupivacaine 0.25% after negative aspiration will be put into the
      potential space between pectoralis minor muscle and serratus muscle (PECS II). After 15
      minutes of the block, surgical incision will be allowed. Drug packs will be prepared before
      commencement of the study by a pharmacist unaware of the nature of the study. Inadequate
      analgesia is defined as more than 20% increase in mean blood pressure and/or heart rate after
      skin incision and during surgical procedure which will be managed by administration of 1
      μg/kg fentanyl. The average end-tidal isoflurane, total intraoperative fentanyl dose will be
      recorded. In case of failure of the block patient will be excluded.At the end of the surgical
      procedure, anesthesia will be discontinued and neuromuscular blockade will be reversed with
      neostigmine(0.05 mg/kg) IV and atropine iv (0.03 mg/kg).Patients will be extubated and
      shifted to the post-anesthesia care unit. In postoperative anaesthesia care unit,
      postoperative monitoring of the hemodynamics will be undergone by a well trained nurse who
      will be blinded to the study and the sensory level of the block was tested using the cold
      test, done by a blinded physician to the nature of the study after the operation.

      .Before induction of anesthesia patients will be teached how to use a 100 cm visual analog
      scale (VAS) 0 =''no pain" and 100 =''worst imaginable pain"). If VAS score > 4 then a rescue
      dose of a fentanyl 1.0 μg kg-1 i.v. bolus will be given.

      The primary outcome measures will include time of performance of each technique.

      The secondary outcomes will include total dose of postoperative fentanyl consumed, visual
      analogue scores in addition to vital signs will be assessed at 2, 6, 10, 12, 18, 24 h by an
      investigator blinded to the group allocation and the nature of the study. postoperative
      adverse events such as hypotension and respiratory depression, postoperative nausea and
      vomiting (PONV) which will be evaluated using a four-point numerical scale (0=no PONV, 1=mild
      nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once). The rescue dose of
      ondansetron 0.1 mg kg-1 will be given i.v. if the score is 2 or more.Moreover, the time to
      first dose of rescue analgesic.
    

Intervention name(s): single needle path PECS I and II block group; double needle path PECS I and II block group
Intervention type(s): Other; Other
Intervention description(s): The probe is placed inferior to the clavicle . The US probe is placed below outer third of the clavicle showing pectoralis major and minor muscles and the thoraco- acromial artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised . The probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles ise identified at 4th rib at the level of thoraco-acromial artery , the needle is inserted in plane with the probe from caudal to cranial using an inclined manner, 15mL of bupivacaine is put into the potential space between pectoralis minor muscle and serratus muscle (PECS II) then it is withdrawn to inject another 15 ml of bupivacaine in the plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic injection is visualised.; The US probe will be initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised, then the needle will be inserted in plane with the probe and 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis muscles. In the second puncture , the US probe will be moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial in an inclined way, 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).
Other intervention name(s): single needle path PECS I and II block; double needle path PECS I and II block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PECS; bupivacaine