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N/A N=71 Randomized Double-blind Treatment

Single Shot Lumbar Erector Spinae Plane (ESP) Block in Total Hip Replacement (THR)

Total Hip Replacement · Analgesia

Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain) — 3; 3 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
single shot lumbar Erector Spinae Plane block (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tuen Mun Hospital
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)
7; 7
PRIMARY
Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)
7; 7
PRIMARY
Post-operative 12 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use
210; 165
PRIMARY
Post-operative 24 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use
409; 349
SECONDARY
Post-operative Nausea and Vomiting (PONV)
11; 10
SECONDARY
Knee Flexion Power (Operative Side)
3; 3

Summary

Total hip replacement is a common orthopaedic procedure that improves pain and mobility in a variety of pathologies like osteoarthritis, rheumatoid arthritis and avascular necrosis. Post-operative complications, for instance, venous thromboembolism and chest infection have long been documented in literature. These complications can have a bearing on long term survival, and may be prevented by early mobilisation. Therefore, pain control plays an important role in enhancing post-operative recovery, which may also shorten length of stay and reduce overall cost. Multimodal analgesia is applied to these patient, with combination of opioid, oral adjuvant and regional anaesthesia. Each of the components has its own limitation; for opioid, post-operative nausea and vomiting (PONV) and respiratory depression limits its use, and adjuvants like non-steroidal anti-inflammatory drugs (NSAID) are contraindicated in certain patient populations (renal impairment, ischaemic heart disease, coagulopathy). Various regional techniques like femoral nerve block, fascia iliaca block, lumbar plexus block, paravertebral block and epidural anaesthesia are proposed but may be limited by incomplete coverage (due to the innervation by femoral and obturator nerve for the anterior aspect of the joint and sciatic nerve for the posterior aspect, with contribution of lateral cutaneous nerve of thigh for the wound), the invasive nature of the regional technique (psoas haematoma for lumbar plexus block, epidural haematoma for epidural anaesthesia (EA)) or cardiovascular effects like hypotension from EA. Erector spinae block, first introduced by in 2016 as a chronic pain intervention, was also used in hip surgery from a case report in 2018. However, currently the evidence for lumbar ESP block is limited mainly to case reports, while randomised control trial is scarce. More concrete data are required to determine the efficacy of this novel technique. It is postulated that single shot lumbar ESP injected at L1 level can 1) reduced post-operative pain score 2) reduced post-operative 24 hour opioid (fentanyl) use. This study is conducted in Tuen Mun hospital (TMH) and Pok Oi hospital (POH) in Hong Kong. Patient are recruited for the study during pre-anaesthetic assessment, and they are counselled for risk of general anaesthesia and erector spinae plane block (i.e. local infection/bleeding, injury to neighbouring structure, local anaesthetic toxicity).

Eligibility Criteria

Inclusion Criteria

  • Adult patients (age >=18)
  • American Society of Anesthesiologists (ASA) class 1-3
  • primary elective unilateral THR
  • understand and accept the risk for general anaesthesia and ESP block
  • counselled of post-operative patient controlled analgesia (PCA) and deemed fit for its use.

Exclusion Criteria

  • emergency THR
  • bilateral THR
  • revision THR
  • THR done under neuraxial technique (e.g. spinal anaesthesia, combined spinal epidural anaesthesia)
  • Patient with contraindication for ESP block (i.e. patient refusal, injection site infection or spine pathology/surgery, coagulopathy with international normalised ratio (INR) > 1.4 and thrombocytopenia = 35)
  • severe obstructive sleep apnea syndrome (Apnoea hypopnoea index >= 30, no matter on treatment or not)
  • patient on regular strong opioid (e.g. morphine, oxycodone, methadone, buprenorphine, fentanyl)
  • patient who have undergone hip neurolysis
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04388553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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