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

Single Shot Lumbar Erector Spinae Plane (ESP) Block in Total Hip Replacement (THR): a Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04388553
Enrollment
71
Registered
2020-05-14
Start date
2020-07-01
Completion date
2021-11-20
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Total Hip Replacement

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).

Detailed description

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.

Interventions

PROCEDUREsingle shot lumbar Erector Spinae Plane block

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

Sponsors

Tuen Mun Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 \< 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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)First post-operative dayat rest
Post-operative 12 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use12 hour post-operativelyin microgram
Post-operative 24 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use24 hour post-operativelyin microgram

Secondary

MeasureTime frameDescription
Post-operative Nausea and Vomiting (PONV)First post-operative dayeither presence of nausea or vomiting of any degree counted as yes
Knee Flexion Power (Operative Side)First post-operative daymeasured in medical research council (MRC) grade with 0 being no movement to maximum of 5 meaning normal power

Countries

Hong Kong

Participant flow

Participants by arm

ArmCount
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
35
Control
no regional anaesthesia is performed nor saline is injected into the ESP
35
Total70

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation10

Baseline characteristics

CharacteristicTreatmentControlTotal
Age, Continuous64.4 years
STANDARD_DEVIATION 10.5
64.7 years
STANDARD_DEVIATION 10.2
64.5 years
STANDARD_DEVIATION 10.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants35 Participants70 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
Hong Kong
35 participants35 participants70 participants
Sex: Female, Male
Female
20 Participants19 Participants39 Participants
Sex: Female, Male
Male
15 Participants16 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 35
other
Total, other adverse events
1 / 350 / 35
serious
Total, serious adverse events
0 / 350 / 35

Outcome results

Primary

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

in microgram

Time frame: 12 hour post-operatively

ArmMeasureValue (MEDIAN)
TreatmentPost-operative 12 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use210 Microgram
ControlPost-operative 12 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use165 Microgram
Primary

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

in microgram

Time frame: 24 hour post-operatively

ArmMeasureValue (MEDIAN)
TreatmentPost-operative 24 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use409 Microgram
ControlPost-operative 24 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use349 Microgram
Primary

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

at rest

Time frame: First post-operative day

ArmMeasureValue (MEDIAN)
TreatmentPost-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)3 score on a scale
ControlPost-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)3 score on a scale
Primary

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

upon mobilisation

Time frame: First post-operative day

ArmMeasureValue (MEDIAN)
TreatmentPost-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)7 score on a scale
ControlPost-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)7 score on a scale
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

Time frame: First post-operative day

ArmMeasureValue (MEDIAN)
TreatmentKnee Flexion Power (Operative Side)3 score on a scale
ControlKnee Flexion Power (Operative Side)3 score on a scale
Secondary

Post-operative Nausea and Vomiting (PONV)

either presence of nausea or vomiting of any degree counted as yes

Time frame: First post-operative day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TreatmentPost-operative Nausea and Vomiting (PONV)11 Participants
ControlPost-operative Nausea and Vomiting (PONV)10 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026