Study the effect of Dexamethasone as adjuvant to regional block of upper extremity surgery.
- Conditions
- Injury, poisoning and certain other consequences of external causes,
- Registration Number
- CTRI/2019/05/018960
- Lead Sponsor
- Manivannan Pachiappan
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 120
- Patients Posted for Upper extremity elective surgery 2.
- American Society of Anesthesiologists physical status class I-II 4.
- Age group : 18-60 years 5.
- BMI < 35 kg/m2.
- Patient refusal 2.
- Pregnancy 3.
- Surgical procedure duration of 180 minutes or longer 4.
- Severe respiratory disease 5.
- Chest or shoulder deformities operating side 6.
- Preexisting neurological deficit or neuropathy 7.
- Allergy to local anesthetics or dexamethasone 8.
- Local skin infection 9.
- Coagulopathy, Bleeding diathesis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Onset, peak and Duration of sensory block Sensory block will be assessed every 5mins upto 30 minutes Block drug 24ml of 0.5% bupivacaine + 6ml distilled water IV drug 10ml saline Median Thumb opposition Radial Thumb Abduction Ulnar Thumb Adduction 2 No Movement Musculocutaneous Nerve lateral aspect of forearm 0 Normal Movement 1 Paresis Musculo-cutaneous Nerve Elbow flexion in Supination and Pronation
- Secondary Outcome Measures
Name Time Method Median Thumb opposition Radial Thumb Abduction 1. Onset, Peak and Duration of motor block 2. Cumulative Postoperative analgesic usage in first 24 hours Musculocutaneous Nerve lateral aspect of forearm 0 Normal Movement Ulnar Thumb Adduction 1 Paresis Musculo-cutaneous Nerve Elbow flexion in Supination and Pronation 2 No Movement
Trial Locations
- Locations (1)
Government Mohan Kumaramangalam Medical college and Hospital
🇮🇳Salem, TAMIL NADU, India
Government Mohan Kumaramangalam Medical college and Hospital🇮🇳Salem, TAMIL NADU, IndiaDr Mohanhariraj AngamuthammalPrincipal investigator9994740519mohanhariraj@gmail.com