comparative study of Nalbuphine and Butorphanol as adjuvant to 0.75%Ropivacaine in Supraclavicular brachial plexus block in patients posted for upper limb surgeries-a double blinded randomized controlled trail

Nil per oral for 6 hours before surgery. Pre medicated with tablet Alprazolam 0.5mg and tablet Pantoprazole 40mg on the night before surgery. Informed written consent for participation in the study will be obtained from each patient.  Patient data will be recorded in the proforma. Details regarding age, sex, contact information, comorbidities, airway assessment and ASA class will be recorded. Enrolled patients will be allotted to one of the groups (A or B). Based on the randomization sequence, the patients will be allocated into two groups, Group A and Group B. Group N patient will receive 20 ml of 0.75%Ropivacaine + 1 ml (10 mg) Nalbuphine and patients belonging to group B will receive 20 ml of 0.75% Ropivacaine + 1 ml (1 mg) Butorphanol After shifting the patient to operation theatre, the ASA standard monitors like ECG, Noninvasive blood pressure (NIBP), SpO2 will be connected and baseline readings will be noted. Strict aseptic precautions will be followed. Blocks will be performed under ultrasound guidance. Ultrasonography machine (Sonosite Edge I ultrasound system) with a high frequency linear array probe (6-13MHz) will be used. Patient will be lying supine and head tilted to opposite side, in both the study groups. For each patient, Inj. Midazolam 0.02 mg/kg IV will be administered and supplemental oxygenation via a simple face-mask at the rate of 4L/min will be administered before performing the block. Blocks in both groups will be performed using a local anesthetic of 20ml of 0.75% Ropivacaine. In the transverse orientation, the probe is placed in the supra clavicular region, approximately 3cm above the midclavicular point. At this site, the third part of SCA will be visible. The probe is toggled in cephalocaudal direction to see SCA and its cross section, along with the three trunks of brachial plexus (hyper-echoic structures) resting on the first rib. After obtaining an adequate sonographic view, a 5 cm, 22 -gauge needle (Stimulex D; B. BRAUN AG) will be inserted in line from the lateral to medial orientation through single skin puncture. Sensory evaluation will be done using pin prick stimulation in the areas supplied by the radial nerve- dorsum of hand, median nerve- thenar eminence, ulnar nerve- hypothenar eminence and musculocutaneous nerve - lateral aspect of the forearm by 3-point scale10. At each point of assessment, a score of 0-2 will be given to each territory Grade 0 – normal sensation A complete sensory blockade of each nerve is defined as a pinprick score of 2. Grade 1 – loss of pain sensation, but pressure sensation intact Grade 2 – loss of both pain and pressure sensation. The motor evaluation is done by elbow flexion (musculocutaneous nerve), third finger flexion (median nerve), thumb abduction (radial nerve) and little finger flexion (ulnar nerve). At each point of assessment, a Modified Bromage scale5 is used to grade motor blockade.

1. Able to raise the extended arm to 90 degrees for a full two seconds.
2. Able to flex the elbow and move the fingers but unable to raise the extended arm
3. Unable to flex the elbow but able to move the fingers
4. Unable to move the arm, elbow or the fingers.Grade 2 corresponds to onset of motor blockade and Grade 3 onwards was taken as complete blockade. A complete motor blockade for each nerve is defined as a score of 0. Block performance time is defined as the time (in minutes) from the point of needle insertion till the removal of the needle after drug deposition. We considered the block successful and the patient ready for surgery when a complete sensory and motor blockade is achieved in all four territories and time to readiness for surgery is recorded. In case of block failure or insufficient block, the patients are administered general anesthesia with standard institutional protocol, and surgery proceeded and such cases will be excluded from statistical analysis. After the surgery, patients will be instructed to repeatedly pinch the little finger of each hand using their non-blocked hand and report for the time of sensory normalization in the anaesthetized hand by comparison with the opposite hand. Patients will be followed up for 24hrs post surgery and looked for residual blockade and neurological deficits. The patient and the postoperative ward staff will be instructed to note the time of return of pain postoperatively which will be verified by the investigator. Blood Pressure (Systolic, Diastolic and Mean Arterial Pressure), heart rate and Peripheral oxygen saturation of the patient will be recorded every 10 minutes from 30mins before the procedure and every 5 minutes after the block for first 30mins and every one hour for next 6 hours or after the end of the surgery and every fourth hourly thereby up to 24 hours after the surgery. Injection Atropine 0.6 mg is given intravenously if the heart Rate decreases below 40 bpm and injection Ephedrine 6 mg will be given intravenously if the Mean Arterial Pressure decreases less than 60 mmHg. The occurrence of postoperative pain will be assessed by the Visual Analogue Score at 2nd hour, 4th hour, 6th hour, 8th hour, 12th hour, 16th hour, 20th hour and 24th hour after the procedure and whenever patient complains of pain. VAS score of >4 will be considered significant and rescue analgesia Inj. Tramadol 1 mg/kg IV stat will be given, the duration of action of drug is determined by onset of action to first rescue analgesia.