Comparison Between Bupivacaine and Ropivacaine in Patients Undergoing Forearm Surgeries Under Brachial Plexus Block
Condition: Effect of Drug
Study type: Interventional

Summary: 
      This prospective comparative randomized study was done to compare Bupivacaine and Ropivacaine
      in patients undergoing forearm surgeries under axillary brachial plexus block. The study
      compares the onset and duration of sensory block, onset and duration of motor block and
      duration of analgesia between these two drugs.
    

Detailed description: 
      This is a prospective comparative randomized study to compare Bupivacaine and Ropivacaine in
      patients undergoing forearm surgeries under axillary brachial plexus block. A sample size of
      100 was considered who are meeting the inclusion and exclusion criteria were selected, and
      divided into two groups of 50 each using computer-generated randomization and allocation
      concealment was done using sealed sequentially numbered containers opaque envelope technique
      (SNOSE). One group will receive Bupivacaine and the other Ropivacaine. Patients were blind to
      the study. In the Bupivacaine group, 30 ml of 0.5% bupivacaine was injected equally divided
      and injected in four nerves (musculocutaneous, median, radial and ulnar nerves). In the
      Ropivacaine group, 30 ml of a solution containing 0.5% ropivacaine was equally divided and
      injected in the four nerves. Sensory block was tested with a 22-gauge hypodermic needle by
      using the pinprick test and compared with the contralateral hand. Sensory block was graded as
      Grade 0: Sharp pin felt, Grade 1: Analgesia, dull sensation felt and Grade 2: Anaesthesia, no
      sensation felt. Motor function was assessed as per the modified Bromage scale. 0: Able to
      raise the extended arm to 90 degrees for a full 2 sec, 1: Able to flex the elbow and move the
      fingers but unable to raise the extended arm, 2: Unable to flex the elbow but able to move
      the fingers and 3: Unable to move the arm, elbow or fingers. The onset of sensory blockade
      was assessed by the time from the completion of injection of the study drug till the loss of
      pinprick sensation. It was assessed every minute. The onset of motor blockade was assessed
      when there was Grade 1 motor blockade. It was assessed every minute. Duration of sensory
      blockade was assessed by the time between onset of sensory blockade and return of dull
      sensation to pinprick. .It was assessed every 15 minutes. Duration of motor blockade was
      assessed by the time between onset of motor blockade and time at which patients could first
      move their fingers. It was assessed every 15minutes. Duration of analgesia is the time
      interval between the onset of sensory block and the patient's first analgesic request. The
      rescue analgesia in the form of inj. Diclofenac sodium (1.5 mg/kg) intramuscularly was given.
      Block was considered to have failed when sensory anaesthesia was not achieved within 30 min.
      General anaesthesia was given subsequently to these patients and was excluded from the study.
      Again, a patient showing an allergic reaction to the intervention were also withdrawn from
      the study.

      Statistical Analysis - Normally distributed quantitative data were presented as mean ± SD,
      whereas data not normally distributed were presented as median (IQR). While comparing
      quantitative data between the two groups, for normally distributed quantitative data,
      Independent student t-test was used, on the other hand, Mann-Whitney test was used. For
      comparing qualitative variable chi-square or Fischer exact test was applied as appropriate.
      In case of repeated measure data, mixed effect ANOVA was used. For all test P value of < 0.05
      was considered as significant and P-value < 0.001 was considered as highly significant. SPSS
      version 21 (IBM, Newyork) was used for data analysis.
    

Intervention name(s): Axillary Brachial plexus block
Intervention type(s): Procedure
Intervention description(s): Brachial plexus block via axillary route was administered using 30 ml of 0.5% Bupivacaine in group B and 30 ml of 0.5% Ropivacaine in Group R
Other intervention name(s): Brachial plexus block for forearm surgeries
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a prospective randomized single-blind study. Patients were blind to the study of drugs. Blinding was achieved by the examiner of the study. Participants were randomly allocated into two groups (Group - B i.e. Bupivacaine Group and Group - R i.e. Ropivacaine group) using computer-generated randomization and allocation concealment was done using sealed sequentially numbered containers opaque envelope technique (SNOSE)
Masking: Single (Participant)
Primary purpose: Treatment