Efficacy of systemic or perineural Dexamethasone as adjuvant to ultrasound guided supraclavicular block.

Supraclavicular brachial plexus block is the most consistent block for upper limb surgeries.

Local anesthetics alone provides analgesia for only 4-8 hrs. Various additives like Opioids , Clonidine etc. prolong analgesia. Steroids have powerful anti inflammatory as well as analgesic property.

Steriods relieve pain by reducing inflammation, blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge.Systemic or perineural administration of steroids enhances efficacy of brachial plexus block. There is Paucity of study of dexamethasone as adjunt for plexus blocks in Indian population. Hence Influence of dexamethasone as a systemic or perineural additive to plexus blockade needs to be evaluated

 Aim:

To compare efficacy of systemic or perineural dexamethasone as an adjunct to ultrasound guided supraclavicular block

Objectives:

To compare the efficacy of Systemic or Perineural Dexamethasone as an adjunct to ultrasound guided Supraclavicular block in terms of

1.    Onset of sensory block and motor blockade

2.    Peak effect of sensory block and motor blockade

3.    Duration of sensory block and motor blockade

4.    Postoperative pain and analgesic requirement

5.    Postoperative patient satisfaction

6.    Observation of complications if any

 Trial Design

Prospective

Interventional

Parallel, Triple arm

Randomized, active controlled

Triple Blinded

Single centre

Materials

LOGIQ- e: Ultrasound machine and High frequency Linear Transducer (12MHZ) to scan the block area

(Wipro GE Healthcare Pvt. Ltd., India)

80mm 22G Sonoplex STIM needles to perform block

(Pajunk GmbH, Germany – Hospimedica International Ltd)

Drugs

1.Inj. Bupivacaine 0.5% plain 20ml vial

(Nandani Medical Laboratories Pvt. Ltd.) (TN Govt. Supply)

2.Inj. Dexamethasone IV 2ml vial (4mg/ml)

(Alves Healthcare Pvt. Ltd.) (Tn Govt. Supply)

 Methodology

Sample size 90 with 30 in each group, Computer generated randomization, allocation concealment by SNOOSE technique,

GROUP

A

B

C

|Block drug

24ml of 0.5% bupivacaine + 6ml distilled water

24ml of 0.5% bupivacaine + 6ml distilled water

24ml of 0.5% bupivacaine + 4ml distilled water + 2ml (8mg) of Dexamethasone

|IV drug

10ml saline

10 ml (8ml saline + 2ml (8mg ) of  Dexamethasone)

10ml saline

Procedure

After shifting the patient to the operating room, baseline monitors will be connected

All subjects will receive

Supplemental oxygen 6L/min via face mask

Procedural sedation with midazolam 0.03 mg/kg and fentanyl 1 microgram/kg

Performers will administer Supraclavicular brachial plexus block under ultrasound guidance using 22 gauge, 80mm short bevel needle with 30 ml block drug along with intravenous injection of  10 ml of IV drug both prepared by research assistant.

After completion of block the primary researcher or secondary researcher will measure and record the following outcomes

Primary Outcome:

Onset, Peak and Duration of sensory block

Secondary Outcomes:

Onset, Peak and Duration of motor block

Cumulative Postoperative analgesic usage in first 24 hours

24th hour VAS

Recording of complications if any (nausea, vomiting, bleeding, technical failure…..)

Sensory block will be assessed every 5 minutes up to 30 minutes (0, 5, 10, 15, 20, 25, 30 mins)

Nerve****Area Assessed
Median Volar aspect of thumb
Radial lateral aspect of dorsum of hand
Ulnar volar aspect of fifth finger
Musculocutaneous Nerve lateral aspect of forearm

The extent of sensory block will be assessed by testing for pin prick with blunted 24G hypodermic needle in the median, radial, ulnar, and musculocutaneous nerve distributions using -3-point score:

Score****Sensations
0 normal sensation
1 dull sensation to pin prick
2 no sensation to pin prick

Onset time is defined as time to dull sensation along any of the nerve distribution after block completion

Peak effect is time to achieve complete loss of sensation along all the four nerve distribution after block completion (score ≥ 7)

Motor block will be assessed every 5 minutes up to 30 minutes

(0, 5, 10, 15, 20, 25, 30 mins)

Nerve****Movement Assessed
Median Thumb opposition
Radial Thumb Abduction
Ulnar Thumb Adduction
Musculo-cutaneous Nerve Elbow flexion in Supination and Pronation

 The extent of motor block will also be tested in the distribution of the median radial, ulnar and musculocutaneous nerves using -3-point scale,

Score****Motor movements
0 Normal Movement
1 Paresis
2 No Movement

Onset time is considered when patient felt heaviness on abduction of arm at shoulder

Peak effect time is considered when patient was unable to perform any of the movement as defined for each individual nerve (score ≥ 7)

Cumulative score of 14 and above in 30 minutes is considered as block success.  Score less than 14 will be recorded as block failure and will be excluded from analysis

Duration of analgesia is the time between sensory onset and time when patient feels pain

Duration of motor block is time between motor onset and time when patient flexes and extends the elbow and wrist with normal power

All Patients will receive oral paracetamol 500mg every six hours as baseline postop analgesia for 24 hours

Inj. Tramadol 100 mg will be given intramuscularly if Visual analogue scale [VAS] ≥4) during the postop period.

The cumulative requirement of opioid during first 24 hours will be recorded.

Other complications if any will be recorded