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Lumbar Plexus Block vs Fascia Iliaca Block After Hip Arthroscopy

Lumbar Plexus Block vs Fascia Iliaca Block After Hip Arthroscopy: A Non-inferiority Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02882633
Enrollment
50
Registered
2016-08-30
Start date
2015-11-30
Completion date
2018-05-31
Last updated
2019-06-11

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

Conditions

Hip Arthroscopy, Nerve Block

Keywords

lumbar plexus block, fascia iliac block, quality of recovery score, pain score

Brief summary

The purpose of this study is to compare lumbar plexus block to fascia iliac block done in adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid consumption, and quality of recovery 48 hours post operatively will be used for comparison.

Detailed description

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups: 1. Lumbar Plexus Block 2. Fascia Iliaca Block The patient will undergo general anesthesia as by the attending anesthesiologist assigned to the case. No intraoperative restrictions will be required for this study. Once in the PACU, the patient will be assessed and if their pain score is ≥ 4 on the NRS, the patient will be randomized to a lumbar plexus block or fascia iliaca block. Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation. The fascia iliaca block will be performed in a standard fashion as described2. The patient will be placed in a supine position. The ipsilateral groin will be prepped and cleaned with chlorhexidine. An ultrasound machine with a linear transducer covered with a sterile tegaderm will be utilized. The transducer is placed inferior to the inguinal ligament until the femoral artery is located. The probe is then moved laterally until the Sartorius muscle is seen. A skin wheal with 3ml of 1% lidocaine is made and a 2-inch blunt tip needle is inserted in plane. The needle is seen to pierce the fascia iliaca and 1-2 ml of 0.25% Preservative Free bupivacaine with 1:200,000 epinephrine is injected to confirm correct needle placement between the fascia iliaca and iliopsoas muscle. An injection will be deemed adequate if local anesthetic is seen to separate these two layers in a medial to lateral direction. A total of 30ml of the above solution will be injected. The lumbar plexus block will be performed with the patient placed in a lateral position with the operative side facing up. An ultrasound machine with a curved transducer covered with a sterile tegaderm will be utilized. The ipsilateral hip and knee will be flexed to 90 degrees. The anatomy for the LP block will be localized using a modified transverse scan of the lumbar paravertebral area (PMTS). This technique is well described by Karmarkar et al.7 The target vertebral level will be identified by locating the lumbosacral junction (the gap of L5-S1) using a paramedian sagittal scan and then counting cranially to locate both the lamina and the transverse process of L3-L5. The transducer is then placed 4 cm lateral to the midline at the L3-4 level and directed medially to insonate the intervertebral foramen through the lumbar intervertebral space. A skin wheal is made at this site with 1% lidocaine. and a 4 inch blunt tip needle is introduced 4 cm lateral to the midline and just medial of the transducer after connecting it to a nerve stimulator set at 1.00 mA. The needle is slowly advanced under ultrasound guidance until engaged in the psoas compartment and a quadriceps twitch is elicited. The nerve stimulator is turned down until the twitch is abolished at 0.3mA or less. 1-2cmlof 0.25% Preservative free Bupivacaine with 1:200,000 epinephrine is injected slowly after negative aspiration. A total of 30ml will be injected. Spread will be confirmed with ultrasound. All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.

Interventions

DRUG30ml bolus of bupivacaine

Local anesthetic

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Adult patients18 years and older scheduled for hip arthroscopy surgery * American Society of Anesthesiologists (ASA) physical status I -III * Mentally competent and able to give consent for enrollment in the study

Exclusion criteria

* Chronic opioid use (use of any opioid daily or on most days of the week for more than 3 months) * Diagnosed peripheral neuropathy in the surgical lower extremity * Allergy to study medications * BMI \>42

Design outcomes

Primary

MeasureTime frameDescription
Pain Score ChangeChange from baseline through 15 minutesChange in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.
Amount of Opiate ConsumptionWhile in PACU. An average length of stay for Lumbar Plexus Block group was 165.04 min and 139.72 min for Fascia Iliaca Block group.Participants need for pain relief as measured by opiate consumption

Secondary

MeasureTime frameDescription
Quality of RecoveryChange from baseline through 24 hoursScore of QoR survey to determine recovery status. 0-18 where 0 is the worst and 18 is the best feeling.

Countries

United States

Participant flow

Participants by arm

ArmCount
Lumbar Plexus Block
Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
23
Fascia Iliaca Block
Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
25
Total48

Baseline characteristics

CharacteristicLumbar Plexus BlockFascia Iliaca BlockTotal
Age, Continuous38.83 years
STANDARD_DEVIATION 11.55
39.8 years
STANDARD_DEVIATION 11.4
39.34 years
STANDARD_DEVIATION 11.36
Body Mass Index29.89 kg/m^2
STANDARD_DEVIATION 6.59
26.80 kg/m^2
STANDARD_DEVIATION 4.52
28.28 kg/m^2
STANDARD_DEVIATION 5.76
Femoral/Acetabular osteoplasty19 Participants23 Participants42 Participants
Peri-trochanteric space surgery4 Participants2 Participants6 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
16 Participants16 Participants32 Participants
Sex: Female, Male
Male
7 Participants9 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 25
other
Total, other adverse events
1 / 230 / 25
serious
Total, serious adverse events
1 / 230 / 25

Outcome results

Primary

Amount of Opiate Consumption

Participants need for pain relief as measured by opiate consumption

Time frame: While in PACU. An average length of stay for Lumbar Plexus Block group was 165.04 min and 139.72 min for Fascia Iliaca Block group.

ArmMeasureValue (MEAN)
Lumbar Plexus BlockAmount of Opiate Consumption16.98 mg
Fascia Iliac BlockAmount of Opiate Consumption20.80 mg
Primary

Pain Score Change

Change in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.

Time frame: Change from baseline through 15 minutes

ArmMeasureValue (MEAN)
Lumbar Plexus BlockPain Score Change3 change in score on a scale
Fascia Iliac BlockPain Score Change1.72 change in score on a scale
Secondary

Quality of Recovery

Score of QoR survey to determine recovery status. 0-18 where 0 is the worst and 18 is the best feeling.

Time frame: Change from baseline through 24 hours

ArmMeasureValue (MEAN)
Lumbar Plexus BlockQuality of Recovery14.52 Score on a scale
Fascia Iliac BlockQuality of Recovery15.91 Score on a scale

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