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

NCT04388553 | Completed Results

• 1 other identifier: NTWC/REC/20007
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Total Hip Replacement; Analgesia

Outcome Measures

Primary Outcomes (4)

• Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)

  at rest

  First post-operative day

• Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)

  upon mobilisation

  First post-operative day

• Post-operative 12 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use

  in microgram

  12 hour post-operatively

• Post-operative 24 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use

  in microgram

  24 hour post-operatively

Secondary Outcomes (2)

• Post-operative Nausea and Vomiting (PONV)

  First post-operative day

• Knee Flexion Power (Operative Side)

  First post-operative day

Study Arms (2)

Treatment

EXPERIMENTAL

lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.

Procedure: single shot lumbar Erector Spinae Plane block

Control

NO INTERVENTION

no regional anaesthesia is performed nor saline is injected into the ESP

Interventions

single shot lumbar Erector Spinae Plane block PROCEDURE

unilateral (operative side), performed at L1 level, under ultrasound guidance

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \< 75 x 10\^9/L)
• patient who are mentally incompetent
• severe obesity (Body Mass Index \>= 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

Sponsors & Collaborators

• Tuen Mun Hospital: lead

Study Sites (1)

Department of Anaesthesia and Intensive Care, Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Related Publications (22)

• Switon A, Wodka-Natkaniec E, Niedzwiedzki L, Gazdzik T, Niedzwiedzki T. Activity and Quality of Life after Total Hip Arthroplasty. Ortop Traumatol Rehabil. 2017 Oct 31;19(5):441-450. doi: 10.5604/01.3001.0010.5823.

  PMID: 29154234 BACKGROUND

• Chandrasekaran S, Ariaretnam SK, Tsung J, Dickison D. Early mobilization after total knee replacement reduces the incidence of deep venous thrombosis. ANZ J Surg. 2009 Jul;79(7-8):526-9. doi: 10.1111/j.1445-2197.2009.04982.x.

  PMID: 19694660 BACKGROUND

• Zhang XY, Ma JB. The efficacy of fascia iliaca compartment block for pain control after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Jan 25;14(1):33. doi: 10.1186/s13018-018-1053-1.

  PMID: 30683117 BACKGROUND

• Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.

  PMID: 30443064 BACKGROUND

• Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

  PMID: 34196965 BACKGROUND

• Gasanova I, Alexander JC, Estrera K, Wells J, Sunna M, Minhajuddin A, Joshi GP. Ultrasound-guided suprainguinal fascia iliaca compartment block versus periarticular infiltration for pain management after total hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2019 Feb;44(2):206-211. doi: 10.1136/rapm-2018-000016.

  PMID: 30700615 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.

  PMID: 22036893 BACKGROUND

• Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.

  PMID: 686873 BACKGROUND

• World Health Organization. ICD-11: International Classification of Diseases (11th Revision). 2019

  BACKGROUND

• Australian and New Zealand College of Anaesthetists. PM01 (Appendix 2): Opioid dose Equivalence - Calculation of Oral Morphine Equivalent Daily Dose (oMEDD). 2021.

  BACKGROUND

• Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009 Nov 10;28(25):3083-107. doi: 10.1002/sim.3697.

  PMID: 19757444 BACKGROUND

• Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Chapman & Hall/CRC; 2008.

  BACKGROUND

• Iwanaga J, Simonds E, Schumacher M, Yilmaz E, Altafulla J, Tubbs RS. Anatomic Study of the Superior Cluneal Nerve and Its Related Groove on the Iliac Crest. World Neurosurg. 2019 May;125:e925-e928. doi: 10.1016/j.wneu.2019.01.210. Epub 2019 Feb 11.

  PMID: 30763748 BACKGROUND

• Davies A, Crossley A, Harper M, O'Loughlin E. Lateral cutaneous femoral nerve blockade-limited skin incision coverage in hip arthroplasty. Anaesth Intensive Care. 2014 Sep;42(5):625-30. doi: 10.1177/0310057X1404200513.

  PMID: 25233177 BACKGROUND

• Tomlinson J, Ondruschka B, Prietzel T, Zwirner J, Hammer N. A systematic review and meta-analysis of the hip capsule innervation and its clinical implications. Sci Rep. 2021 Mar 5;11(1):5299. doi: 10.1038/s41598-021-84345-z.

  PMID: 33674621 BACKGROUND

• Gadsden J, Warlick A. Regional anesthesia for the trauma patient: improving patient outcomes. Local Reg Anesth. 2015 Aug 12;8:45-55. doi: 10.2147/LRA.S55322. eCollection 2015.

  PMID: 26316813 BACKGROUND

• Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647. doi: 10.1016/j.jclinane.2022.110647. Epub 2022 Jan 11.

  PMID: 35030493 BACKGROUND

• Kokar S, Ertas A, Mercan O, Yildirim FG, Tastan OA, Akgun K. The lumbar erector spinae plane block: a cadaveric study. Turk J Med Sci. 2022 Feb;52(1):229-236. doi: 10.3906/sag-2107-83. Epub 2022 Feb 22.

  PMID: 34773689 BACKGROUND

• Soffin EM, Okano I, Oezel L, Arzani A, Sama AA, Cammisa FP, Girardi FP, Hughes AP. Impact of ultrasound-guided erector spinae plane block on outcomes after lumbar spinal fusion: a retrospective propensity score matched study of 242 patients. Reg Anesth Pain Med. 2022 Feb;47(2):79-86. doi: 10.1136/rapm-2021-103199. Epub 2021 Nov 17.

  PMID: 34795027 BACKGROUND

• Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.

  PMID: 29864216 BACKGROUND

• Abdelnasser A, Zoheir H, Rady A, Ramzy M, Abdelhamid BM. Effectiveness of ultrasound-guided erector spinae plane block for postoperative pain control in hip replacement surgeries; A pilot study. J Clin Anesth. 2020 Jun;62:109732. doi: 10.1016/j.jclinane.2020.109732. Epub 2020 Jan 25. No abstract available.

  PMID: 31986435 BACKGROUND

• Chan A, Ng TKT, Tang BYH. Single-Shot Lumbar Erector Spinae Plane Block in Total Hip Replacement: A Randomized Clinical Trial. Anesth Analg. 2022 Oct 1;135(4):829-836. doi: 10.1213/ANE.0000000000006162. Epub 2022 Aug 1.

  PMID: 35913722 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anyon Chan
• Organization: Tuen Mun Hospital

Ca663@ha.org.hk

24680000

Study Officials

• Tony KT Ng

  Department of Anaesthesia and Intensive Care, Tuen Muen Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After the patient is put under GA and turned lateral, the sealed opaque envelope is opened. Unilateral lumbar ESP block is performed in participants under treatment arm, while no regional block is performed for control arm. The patient is assessed by an independent assessor from the acute pain service team 24 hours after the operation, who is blinded from the allocation result.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Resident Trainee in Department of Anaesthesia and Intensive Care, Tuen Muen Hospital, New Territories West Cluster, HKSAR

Model Details: For the treatment arm, lumbar ESP block is performed while for control arm no regional anaesthesia is performed nor saline is injected into the ESP. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 14, 2020
• Study Start: July 1, 2020
• Primary Completion: November 20, 2021
• Study Completion: November 20, 2021
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data available up to 1 year after completion of study
• Access Criteria: for validation of study results or for compilation of systemic review/meta-analysis

Locations

HK (1)