Comparison of classical midline approach versus modified paramedian approach in spinal Anaesthesia for lower limb orthopedic surgeries in elderly patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- success rates and lesser number of attempts
Study Overview
Brief Summary
After approval from ethical committee, patients posted for lower limb orthopedic surgeries in geriatric age from the Department of Orthopaedics surgery will be taken for study after obtaining written and informed consent, anaesthetic checkup will be done on those patients who fit into the inclusion criteria will be analyzed thoroughly and taken up for the study.
Randomization will be done by computer generated card of patient and allocated into two equal groups: Group A and Group B
Group A: Patients who are receiving classical midline neuraxial block (n=40)
Group B: Patients who are receiving modified paramedian neuraxial block (n=40)
During the procedure, number of attempts, time taken to perform the spinal anaesthesia will be recorded. After the procedure, standard monitoring of ECG, pulse oximetry and non-invasive blood pressure for 30minutes.
After adequate eye opening and maintenance of airway reflexes patients would be transferred post anesthesia recovery unit. All patients are followed up by postoperatively for 24 hours.
Further patients will be assessed for the efficacy of post operative analgesia using the VAS score and will be monitored for other variables such as complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 65.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient posted for elective lower limb orthopedic surgeries under ASA I and II with BMI 18.5-29.9 (normal and overweight category).
Exclusion Criteria
- •Emergency lower limb orthopedic surgeries.
- •Refusal to participation.
- •Allergic to local anaesthetic and adjuvants.
- •Contraindications to Spinal anaesthesia Local infections.
Outcomes
Primary Outcomes
success rates and lesser number of attempts
Time Frame: 30minutes
Secondary Outcomes
- To assess the occurrence of side effects such as headache, nausea, vomiting within 24 hours of operation and Visual analogue scale for low back pain.(24 hours)
Investigators
Dr Gopikrishnan
shri sathya sai medical college and research institute