A study to find minimum volume of a particular local painkiller drug required for ultrasound guided forearm nerve block

Recruiting

Conditions: Unspecified fracture of forearm, (2) ICD-10 Condition: S529||Unspecified fracture of forearm,

Registration Number: CTRI/2020/01/022714

Lead Sponsor: all india institute of medical sciences

Brief Summary: The primary objective is to find the minimum effective volume of 0.5% ropivacaine in 90% patients ( MEV90) for ultrasound guided costoclavicular approach of infraclavicular brachial plexus block for which adults between 18 to 65 yrs undergoing hand wrist and elbow surgery will be chosen , excluding the above mentioned categories . Then after preanaesthetic check up and explaining pain score to patients selected ultrasound guided block will be given prior to surgery . The volume of the drug will be based on baised coin method and up and down sequece in which volume of the drug for next patient is based on result of the previous . The initial volume will be 20 ml and based on the success of this the next volume will be 2ml lesser , this initial volume is based on the study done supraclavicular for MEV 50 which was 23 ml . After block application success will be assessed based on sensory and motor blockade scoring at the end of 30 min. The maximum volume decided is 25 ml to avoid drug toxicity . If the block fails then next patient will get 25 ml . A fixed minimum no of 20 positive responses will be chosen for our dose finding study. The final sample is estimated by simulations to be 52 plus/minus 2 .

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 50

Inclusion Criteria

All adults posted for surgeries of elbow , forearm , wrist and hand American society of anaesthesia grade I/II patient Body mass index 18 to 30 kg/ m sq.

Exclusion Criteria

Patients refusal for brachial plexus block Sepsis coagulopathy Known neuropathy or injury of musculocutaneous , radial , ulnar or median nerve Known allergy to local anaesthetic drugs Abnormal neck or shoulder anatomy Previous surgery in infraclavicular fossa.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to calculate mev of ropivacaine in 90% of patients for costocavicular bliock	Adequate surgical anaesthesia at 30 minutes post block assessment interval

Secondary Outcome Measures

Name	Time	Method
1.Supplementation required to achieve adequate surgical anaesthesia	2.Tourniquet pain

Trial Locations

Locations (1): Deptt of anaesthesiology , pain medicine and critical care
🇮🇳
Delhi, DELHI, India
Deptt of anaesthesiology , pain medicine and critical care
🇮🇳Delhi, DELHI, India
Bijaya Laxmi
Principal investigator
9013923036
daulatia353@gmail.com