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Is Erector Spinae Plane block a replacement for epidural analgesia for pain relief after Hip replacement surgery? A comparative study.

Phase 3
Completed
Conditions
Bilateral primary osteoarthritis of hip, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, (3) ICD-10 Condition: M131||Monoarthritis, not elsewhere classified, (4) ICD-10 Condition: M16||Osteoarthritis of hip,
Registration Number
CTRI/2020/09/027663
Lead Sponsor
Dr Mathew George
Brief Summary

We are attempting to compare a new analgesic block- erector spinal plane block, to the current standard analgesia after hip surgery that is epidural analgesia. Epidural analgesia is associated with certain shortcomings in the postoperative period, and thus erector spinal plane block is being evaluated as a suitable alternative.

Our study design aims to include patients undergoing hip arthroplasty surgery who will be randomised to receive either technique. Participants will be blinded to the analgesic technique being used. Postoperatively the patients will be evaluated for 24 hours by the attending nursing staff in the recovery area with special emphasis on their pain relief as assessed by Numerical Rating Scale (1-10) and incidence of any complications if any, with respect to the analgesic technique provided. All patients will be given supplemental analgesia with intravenous agents in case their block appears to be ineffective. We will be analysing based on a Number Needed to treat analysis.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
34
Inclusion Criteria

Adult patients planned for elective hip replacement surgery belonging to American Society of Anesthetists Physical Status 1 to 3.

Exclusion Criteria
  • Patient refusal 2.
  • Known allergy to local anesthetics 3.
  • Infection at site 4.
  • Bleeding diathesis or patients on any anti-coagulants 5.
  • Inability to provide informed consent 6.
  • ASA PS 4 or 5 patients.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Adequacy of analgesia as assessed by the Numeric Rating Score for post -operative acute pain, and difference in narcotic consumption between the 2 groupsHourly for the first 6 hours postoperatively and second hourly after that up to 24 hours post-operatively
Secondary Outcome Measures
NameTimeMethod
Incidence of analgesic technique related adverse effects or complications in the post-operative period. This includes hypotension, urinary retention, paraesthesia, bleeding from block site and motor blockadeHourly for the first 6 hours postoperatively and second hourly after that up to 24 hours post-operatively

Trial Locations

Locations (1)

Amrita Institute of Medical Sciences & Research Centre

🇮🇳

Ernakulam, KERALA, India

Amrita Institute of Medical Sciences & Research Centre
🇮🇳Ernakulam, KERALA, India
Dr Mathew George
Principal investigator
9447841795
mathew.doc@gmail.com

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