COMPARISON OF ROPIVACAINE (0.5%) AND LEVOBUPIVACAINE (0.5%) IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN UPPER LIMB ORTHOPAEDIC SURGERIES
- Conditions
- Fracture of shoulder and upper arm,
- Registration Number
- CTRI/2023/06/054260
- Lead Sponsor
- YOGINI KELAWALA
- Brief Summary
• Peripheral nerve block is particularly advantageous in case of prolonged orthopaedic, plastic reconstructive surgeries , emergency surgeries and in high risk patients.
• Newer anaesthetic drugs like levobupivacaine and ropivacaine have fewer adverse effects on cardiovascular and central nervous system when compared with bupivacaine making them more advantageous in regional anaesthesia technique.
• Ropivacaine , the S-enantiomer of S- 1-propyl -2’ ,6’ –pipecoloxylidide is an amino amide local anaesthetic agent. It is chemically similar to bupivacaine, butyl group being replaced by propyl group, produces similar sensory and motor blockade, with less cardiac and CNS toxicity compared to bupivacaine. [7]
• Levobupivacaine is the S(-) enantiomer of racemic bupivacaine . R- and S- enantiomers of local anaesthetics have been demonstrated to have different affinity for different ion channels of sodium, potassium and calcium and this results in significant reduction in cardiac and central nervous system toxicity of S – enantiomer as compared with R-enantiomer.
**Study Procedure**
A prospective, randomized, double blind comparative study will be carried out after Institutional Review Board (IRB) approval and informed written consent of patient will be taken in the Department of Anesthesiology, Sir T General Hospital, Govt. Medical College, Bhavnagar, Gujarat, India.
1st step:Preoperative evaluation will be done in all the study population with detailed case history, general examination, assessment of airway and evaluation of investigation.
2nd step: 94 patients will be randomised using computer generated random number sequence method in two groups.
• Group R- Receiving Inj. Ropivacaine hydrochloride (0.5%)30cc.
• Group L- Receiving Inj. Levobupivacaine hydrochloride(0.5%) 30cc.
• Double blinding will be done by drawing lots labelled group-R and group-L and documenting their hospital number on the lot assigned.
3rd step: Brachial plexus block will be performed by supraclavicular approach.
4th step: Patients will be evaluated for motor and sensory blockade .The onset and duration of both motor and sensory blockade will be noted. Also the duration of analgesia will be noted in both groups.
5th step: Patients will be monitored for vital parameters (HR,MAP,SpO2) and complications ,if any(hypotension, bradycardia, nausea, vomiting).
6th step: Patient will be evaluated for rescue analgesia requirement .
**METHODOLOGY**
• After written & informed consent from patient in vernacular language, approval from ethical committee, preoperative evaluation will be done in all the study population with detailed case history, general examination, assessment of airway and evaluation of investigation.
• Randomisation will be done by single trained anaesthetist not involved in study.
• The study drug will be prepared and coded by an anesthesiologist not involved in the study.
• Senior anesthesiologist other than principal investigator will perform the brachial plexus block and PI will be, responsible for monitoring of the patient.
• Patient will be evaluated for onset and duration of sensory and motor blockade using the Hollmen scale and modified Bromage scale.
• All data will be entered into master chart ,detailed analysis will be done and appropriate statistics will be carried out.
• Preoperative evaluation will be done in all the study population with detailed case history, general examination, assessment of airway and evaluation of investigation.
• Randomisation will be done by single trained anaesthetist not involved in study.
• 60 patients will be randomised using computer generated random number sequence method in two groups.
• Group L- Receiving 0.5% Inj. Levobupivacaine hydrochloride 30cc
• Group R- Receiving 0.5% Inj. Ropivacaine hydrochloride 30cc
• Double blinding will be done by drawing lots labelled group-L and group-R and documenting their hospital number on the lot assigned.
• After patient taking on operation table and monitor using pulse oximeter, ecg and non invasive blood pressure .
• An intravenous access was secured using an in dwelling canula of appropriate size.
• Brachial plexus block was performed by supraclavicular approach.
• Patient will be positioned supine with head turned about 30 degree to contralateral side.
• After palpating the interscalene groove and tracing it to most inferior point, which is just posterior to subclavian arterial pulse , the later can be felt in plane just medial to midpoint of clavicle.
• The local infiltration with 2% 2cc Lignocaine will be done to minimize needle pain.
• A 22G,50mm stimuplex needle with nerve stimulator will be directed just above and posterior to subclavian arterial pulse and will be directed caudally at a very flat angle against the skin. The needle will be advanced until flexion of finger will be noted.
• If contraction will still be observed with intensity of stimulating current decreased to 0.5mA,then following protocol : Group –L will receive 30cc of 0.5% Inj. Levobupivacaine hydrochloride and Group –R will receive 30cc of 0.5% Inj. Ropivacaine hydrochloride.
• Patient will be evaluated to determine loss of arm abduction (Deltoid sign as a sign of successive motor blockade).
• Sensory block will be assessed by pin prick over surgical site.
• Surgery will be allowed to begin 30minutes after successful block.
• End of performing the injection will be taken as time zero.
• Pain will be assess using Visual Analogue Scale(VAS),graded from 0 to 10.
• Onset of sensory block: Time between end of performing injection to loss of pinprick sensation.
• Onset of motor block: Time required from completion of drug to loss of motor power.
• Duration of sensory block: Time between onset of sensory block and return of dull pain and VAS<4.[5]
• Duration of motor blockade: Time between onset of motor block and regained ability of patient to move fingers.
• Duration of analgesia : Time between onset of action and onset of pain (VAS >4)and time when patient receive the first dose of rescue analgesia.
• Rescue analgesia: Inj. Diclofenac 1.5 mg/kg iv.
• Patient will be monitored for cardiovascular or CNS toxicity(changes in BP,HR, signs/symptoms of CNS stimulation).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 94
- Patients with ASA Grade I,II and III of either gender.
- All patients undergoing elective and emergency upper limb orthopaedic surgeries.
- Age group of 18 to 65 years.
- Patient with body weight upto 80 kg.
Patient having hypersensitivity to the study drugs by taking history.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To access time of rescue analgesia in both the groups. AT THE END OF 15 MONTHS To estimate onset of sensory block in both the groups. AT THE END OF 15 MONTHS To estimate duration of sensory block in both the groups. AT THE END OF 15 MONTHS To estimate onset of motor block in both the groups. AT THE END OF 15 MONTHS To estimate duration of motor block in both the groups. AT THE END OF 15 MONTHS
- Secondary Outcome Measures
Name Time Method To observe changes in HR,MAP, SpO2 in both the groups. To compare side effects like hypotension, bradycardia, nausea, vomiting in both the groups.
Trial Locations
- Locations (1)
SIR T General Hospital, Bhavnagar
🇮🇳Bhavnagar, GUJARAT, India
SIR T General Hospital, Bhavnagar🇮🇳Bhavnagar, GUJARAT, IndiaYOGINI KELAWALAPrincipal investigator9586448984yk2482682@gmail.com