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Clinical Trials/CTRI/2021/04/032741
CTRI/2021/04/032741CompletedNot Applicable

Efficacy of ultrasound guided erector spinae plane block for post-operative pain relief in hip joint and proximal femur surgeries- A randomised controlled study

Hetal Kotecha1 site in 1 country86 target enrollmentStarted: April 15, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
86
Locations
1
Primary Endpoint
Duration of Analgesia and
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

  • Aim of the study is to know efficacy of ultrasound guided erector spinae plane block for post-operative pain relief in hip joint and proximal femur surgeries.
  • Patients suitable for study as per inclusion criteria, admitted in SSG Hospital will be selected.
  • Demographic details, History, Investigations will be assessed and general examination, systemic examination will be done
  • Patients will be randomly divided into two groups after surgery being done under spinal anaesthesia. 3 ml of Hyperbaric bupivacaine 0.5% will be given in spinal anaesthesia.
  • Case group will be given ultrasound guided lumbar erector spinae plane block 4-6 cm lateral to spinous process and superficial to transverse process of L4 vertebra in the erector spinae plane. Total 30 cc local anaesthetic drug- 0.25% Bupivacaine will be injected using convex ultrasound transducer probe using out plane approach.
  • Control group will be given injection tramadol 1.5 mg/kg intravenously in 100 ml Normal saline as infusion.
  • Patients will be monitored for duration of analgesia using VAS score, Rescue analgesics required in 24 hours, Vital parameters and complications associated with block.
  • VAS (Visual Analogue Scale) score will be assessed every 1 hourly for first 6 hours and every 6 hourly for next 24 hours.
  • Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg intravenously at VAS score>4.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA grading- I,II,III Patient posted for hip joint and proximal femur surgeries Patient able to give verbal and informed consent Patient able to understand VAS regarding assessment of Pain.

Exclusion Criteria

  • •Patient not willing Allergy to local anesthetics Contraindication of spinal, regional anaesthesia Patient with coagulopathy, local infection Patient with pre-existing neurological deficits Patient with history of drug or alcohol abuse, psychiatric illness Patient with pelvic fracture.

Outcomes

Primary Outcomes

Duration of Analgesia and

Time Frame: Pain will be assessed using VAS (Visual Analogue Scale) score every 1 hour for first 6 hours and every 6 hours for next 24 hours | Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg iv at VAS score more than 4

No of Rescue analgesic requirement within 24 hours

Time Frame: Pain will be assessed using VAS (Visual Analogue Scale) score every 1 hour for first 6 hours and every 6 hours for next 24 hours | Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg iv at VAS score more than 4

Secondary Outcomes

  • Vital parameters and(Complications associated with block)

Investigators

Sponsor
Hetal Kotecha
Sponsor Class
Other [self]

Study Sites (1)

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