Comparing the Efficacy and Safety of Ultrasound Guided Supraclavicular Block Combined With Either Intercostobrachialor Pec 11for Creation of Surgical Brachio-basilic Fistula in Chronic Renal Failure Patients on Hemodialysis
Condition: Best Regional Nerve Block for Creation of Surgical Brachiobasilic Fistula
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      In our study we are trying to reach to the more efficient us guided peripheral nerve block
      either intercosto-brachial or PPEC 11 that can be combined with us guided supraclavicular
      block to effectively anesthetise the surgical site for creation of brachio-basilic fistula as
      regarding onset of surgical anesthesia, adequacy of intra-operative anesthesia, the need for
      surgical wound infiltration, duration of postoperative analgesia and the failure rate of the
      fistulae.
    

Detailed description: 
      -  Type of Study: Randomized Prospective trail

        -  Study Setting: Ain Shams University Hospitals, Cairo, Egypt

        -  Study Period: 6 months.

      Sampling Method: Patients will be subdivided randomly into two groups :

      Group (SI) : 25 ml of bupivacaine 0.5 % for us guided supraclavicular block plus 10 ml of
      lidocaine 2% for us guided intercostobrachial nerve block.

      Group(SP) : 25 ml of bupivacaine 0.5 % for us guided supraclavicular block plus10 ml of
      lidocaine 2% for us guided PECll block.

      Study Procedures:

      Following local university ethical committee approval, informed consent will be obtained.
      Details of the anesthetic technique and the study protocol will be fully explained at the
      preoperative visit, and written consent will be obtained from each patient before inclusion
      in the study. The patients has to have normal prothrombin (PT) and partial thromboplastin
      (PTT) times before the procedure.

      In the pre-induction room the patients will be taught how to assess their own pain score
      using the numerical rating scale (NRS) (0-10; 0 = no pain, 10 = worst imaginable pain) .

      On arrival at the operating room, standard monitoring will be established with five lead
      electrocardiogram, non-invasive blood pressure measurement and pulse oximeter. After
      insertion of a 20-gauge intravenous cannula in the non operated arm, an intravenous
      crystalloid solution will be administered. Supplemental oxygen will be supplied through nasal
      cannula. The oxygen flow will be set at 3 L/ min.

      Patients will receive 1-2 md midazolam intravenous as premedication before the block. All
      blocks will be performed by one of the authors, The patients will be randomly allocated to
      one of the two groups, either supraclavicular-intercostobrachial group(SI Group) ,or the
      supraclavicular-Pec 11 group(SP Group) .

      The patient in SI Group is placed in a semi-sitting position by elevating the head of bed 45
      degrees with the patients head turned to the opposite site to be blocked. The skin of the
      neck and the upper chest and axilla and medial upper arm will be prepared in an aseptic
      fashion. Ultrasound examination of the supraclavicular area will be performed using a 38-mm
      high frequency (9-12 MHz) linear array transducer with the in-plane approach, will receive 25
      ml of 0.5% bupivacaine in the supraclavicular area ,then the operated arm will be abducted
      and externally rotated, and the elbow flexed to 90°. Ultrasound examination of the medial
      upper arm will be performed using a 38-mm high frequency (9-12 MHz) linear array transducer
      and the intercosto-brachial nerve is identified and blocked using 10 ml of lidocaine 2% . The
      patient in SP Group will also have supraclavicular block that will be performed in the same
      way as the previous group and then patient is placed in the supine position with the arm
      abducted 90 degrees position to receive Peg 11 lock by injecting 10ml of lidocaine 2% between
      pectoralis minor and serratus anterior at 3rd rib level using a 38-mm high frequency (9-12
      MHz) linear array transducer with the in-plane approach. The sensory and motor blocks will be
      evaluated every 5 min for 30 min or until blocks will be complete. An adequate surgical
      anesthesia will be defined as a motor score of ≥1 , with an absence of pinprick sensations in
      the area of all the four terminal nerves.

      The zero time for onset of sensory and motor blocks will be the completion of the LA
      injection. Sensory block assessment (0, no block 1, loss of sensation of pinprick 2, loss of
      sensation of touch) will be performed in the innervations of the four nerve areas, radial
      (radial dorsum of the hand), median (thenar eminence), ulnar (hypothenar eminence),and
      intercostobrachial (medial upper arm) corresponding to the nerve distributions in the forearm
      and hand using the pinprick test, and will be compared with the same stimulation on the
      contra-lateral arm. The degree of motor block will be evaluated by thumb abduction (radial
      nerve), thumb adduction (ulnar nerve), and thumb opposition (median nerve), using a 3-point
      scale (0 =normal motor function, 1 = decreased motor strength, 2 = complete motor block). The
      onset times of the sensory block (the time between the end of the LA injection and the total
      abolition of the pinprick response) and motor block (time between the end of the LA injection
      and complete motor block) will be recorded for each nerve. Patients who will not achieve
      satisfactory levels of anesthesia and will need intraoperative local infiltration will be
      recorded .Patient in whom the block failed and local infiltration is not enough will receive
      general anesthesia (propofol 2mg/kg plus fentanyl 1ug/kg and atracurium 0.5mg/kg ) with
      laryngeal mask airway inserted for mechanical ventilation .

      Postoperative pain will be assessed by one of the authors using a visual analog scale (0, no
      pain; 10, worst pain imaginable). Analgesic for the first complain of pain will be
      standardized and consisted of 500 mg of oral or intravenous paracetamol given for a pain
      score of 4 of visual analog scale.The time to first analgesic requirement will be also
      recorded by the same author.

      Heart rate, peripheral oxygen saturation, respiratory rate, and blood pressure will be
      measured before the supraclavicular block and 5, 10, 20, 30, 45, and 60 min after the block
      and thereafter every 60 min for 2 h postoperatively. University of Michigan Sedation Scale
      (UMSS) (1, awake and alert; 2, sedated, responding to verbal stimulus; 3, sedated, responding
      to strong physical stimulus; 4, not arousable) will be measured first as baseline before the
      block then at the same time points for measuring vital signs post-block .
    

Intervention name(s): regional anesthesia for the upper limb
Intervention type(s): Procedure
Intervention description(s): pecs-II block and intercostal nerve block
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Health Services Research