Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
After a pilot study regarding opioid use for patient after THR, the sample size for either treatment or control arm is calculated to be 35 patients per group to achieve adequate power to detect such a difference.
Sealed opaque envelopes with allocation inside is prepared forehand and is subsequently drawn on the day of surgery. The attending anaesthetist receives the envelope right before induction, and opens the envelope after the patient is put under general anaesthesia (GA). If the operation is cancelled or the patient cannot use PCA post-operatively (e.g. post-operative mechanical ventilation) or post-operative delirium), the envelope is put back into the pool.
After the patient is put under GA and turned lateral, the envelope is opened. 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.
After the injection, the surgeon is told not to infiltrate any local anaesthetics into the incision site or the wound. Intra-operatively, intravenous fentanyl is given as the only analgesic by the attending anaesthetist. Post-operatively, the patient is given fentanyl PCA of standard setting anaesthetist). The patient is also given all the pre-operative regular oral analgesic agents post-operatively, including paracetamol, NSAID, gabapentinoid and/or weak opioid (DF118 or tramadol).
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. Primary outcomes, that are post-operative 12 and 24 hour PCA fentanyl use and pain score in numeric rating scale (NRS) from 0 to 10 at rest and upon mobilisation are assessed and documented in the electronic system and also the patient chart. Secondary outcomes like presence/absence of PONV and knee flexion power in MRC scale are also noted.
The data are collected by the investigator and input to Excel 2003. 2-sided student's t test is used to compare the primary outcomes and also knee flexion power between treatment group and control group, while the rate of PONV between two groups is compared by Chi-square test. Multi-variate regression is done to control for the effect of oral analgesics on study outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | no regional anaesthesia is performed nor saline is injected into the ESP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single shot lumbar Erector Spinae Plane block | Procedure | unilateral (operative side), performed at L1 level, under ultrasound guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Nausea and Vomiting (PONV) | either presence of nausea or vomiting of any degree counted as yes | First post-operative day |
| Knee Flexion Power (Operative Side) | measured in medical research council (MRC) grade with 0 being no movement to maximum of 5 meaning normal power |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tony KT Ng | Department of Anaesthesia and Intensive Care, Tuen Muen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesia and Intensive Care, Tuen Mun Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29154234 | Background | 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. | |
| 19694660 | 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. |
Not provided
Not provided
data including patient number, age, gender, ASA class, anaesthetic technique, assignment, 24 hour fentanyl use, pain score, PONV and knee flexion power are available upon request by email to principal investigator
data available up to 1 year after completion of study
for validation of study results or for compilation of systemic review/meta-analysis
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 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. single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance |
| FG001 | Control | no regional anaesthesia is performed nor saline is injected into the ESP |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 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. single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain) | at rest | Posted | Median | Inter-Quartile Range | score on a scale | First post-operative day |
|
24 hour post-operatively
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 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. single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged motor block | Injury, poisoning and procedural complications | Non-systematic Assessment | Prolonged lower limb weakness which resolved spontaneously after 3 weeks |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anyon Chan | Tuen Mun Hospital | 24680000 | +852 | Ca663@ha.org.hk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2020 | Apr 13, 2024 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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.
Not provided
Not provided
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.
| First post-operative day |
| 30683117 | 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. |
| 30443064 | 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. |
| 34196965 | 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. |
| 30700615 | 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. |
| 22036893 | 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. |
| 686873 | 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. |
| 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. |
| 19757444 | 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. |
| Background | Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Chapman & Hall/CRC; 2008. |
| 30763748 | 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. |
| 25233177 | 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. |
| 33674621 | 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. |
| 26316813 | 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. |
| 35030493 | 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. |
| 34773689 | 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. |
| 34795027 | 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. |
| 29864216 | 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. |
| 31986435 | 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. |
| 35913722 | Derived | 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. |
| BG001 |
| Control |
no regional anaesthesia is performed nor saline is injected into the ESP |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain) | upon mobilisation | Posted | Median | Inter-Quartile Range | score on a scale | First post-operative day |
|
|
|
| Primary | Post-operative 12 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use | in microgram | Posted | Median | Inter-Quartile Range | Microgram | 12 hour post-operatively |
|
|
|
| Primary | Post-operative 24 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use | in microgram | Posted | Median | Inter-Quartile Range | Microgram | 24 hour post-operatively |
|
|
|
| Secondary | Post-operative Nausea and Vomiting (PONV) | either presence of nausea or vomiting of any degree counted as yes | Posted | Count of Participants | Participants | First post-operative day |
|
|
|
| Secondary | Knee Flexion Power (Operative Side) | measured in medical research council (MRC) grade with 0 being no movement to maximum of 5 meaning normal power | Posted | Median | Inter-Quartile Range | score on a scale | First post-operative day |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | Control | no regional anaesthesia is performed nor saline is injected into the ESP | 0 | 35 | 0 | 35 | 0 | 35 |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |