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â??Comparison of standard blind technique with preprocedural use of ultrasound for Epidural component of Combined Spinal Epidural Block in patients undergoing joint replacement surgeries"

â??A study to compare the use of ultrasound and conventional blind technique for Epidural neuraxial blockade in orthopaedic joint replacement surgeries : A randomised control trialâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009137
Enrollment
210
Registered
2017-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ASA l-lll patients with age more than 50 years , BMIequal to / more than 30 kg/m2 posted for joint replacement surgeries under combined spinal epidural anaesthesia Health Condition 2: M16- Osteoarthritis of hip Health Condition 3: M17- Osteoarthritis of knee

Interventions

Intervention1: Preprocedural use of ultrasound: In group "B" preprocedural use of ultrasound for identifying level of intervertebral space,needle insertion site and Epidural Depth was done. Epidural d

Sponsors

Max Super Speciality hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing orthopaedic joint replacement surgeries 2. Patients with age more than 50 years 3. ASA I-III patients 4. Patients able to provide own consent 5. Patients with BMI >= 30 kg/m2

Exclusion criteria

Exclusion criteria: 1. ASA IV - V patients 2. Patients with known hypersensitivity to local anaesthetics 3. Patients with bleeding disorders 4. Patients on anticoagulants 5. Patients with infection at neuraxial blockade site

Design outcomes

Primary

MeasureTime frame
Rate of successful epidural block on the first needle insertion attempt in both groups with blind conventional technique and preprocedural use of ultrasoundTimepoint: zero seconds /minutes or few seconds after local infilteration

Secondary

MeasureTime frame
Correlation of depth of the epidural space measured with an Ultrasound and LOR technique.Timepoint: zero seconds / minutes or few seconds after local infilteration;Number of Accidental Dural Puncture by Tuohys needle of Combined Spinal Epidural setTimepoint: at Zero second /minutes or few seconds after local infilteration;Number of failed block A failed epidural was defined as a block providing inadequate analgesia (VAS â?¥ 4/10) despite the following sequential steps: 10 ml bolus of 0.5% Bupivacaine ,Second dose of 10 ml bolus of 0.5% Bupivacaine and third 5mL 2% Lidocaine bolus Timepoint: 10,20 and 30 minutes of initiation of epidural infusion postoperatively and 3.5, 4,4.5 and 5 hours from insertion of epidural catheter In case of failed block, reassessment every 15 minutes;Number of needle insertion attempts required for successful epidural block A needle insertion attempt was defined as needle insertion preceded by complete withdrawal of the Tuohyâ??s needle from the patientâ??s skin.Timepoint: zero sec/min few seconds after local infilteration;Number of needle passes (insertion and redirection attempts) required for successful epidural block A needle redirection attempt was defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patientâ??s skin. A needle pass was defined either as needle insertion or redirection attempt. Timepoint: Zero seconds/minutes or few seconds after local infilteration;Patient Satisfaction ScoreTimepoint: 3.5,4,4.5 and 5 hours after insertion of epidural catheter;The efficacy of the epidural component of combined spinal epidural anaesthesiaTimepoint: determined by pain relief (VAS) after 30 minutes of initiation of epidural infusion postoperatively after return of toe movements and patient satisfaction after 5 hours of epidural catheter insertion.These were the end points of the study.;Visual Analog ScaleTimepoint: 10.20 and 30 minutes after initiation of Epidural

Countries

India

Contacts

Public ContactDr Arun Puri Guide

Max super Speciality Hospital, A unit of Balaji Medical and Diagnostic Research Centre

vikkyjaiswal34@gmail.com9582265897

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026