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Femoral/Sciatic Block for Knee Surgery

Continuous Femoral Nerve Blockade and Single Shot Sciatic Nerve Block Compared to Intrathecal Morphine for Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02882152
Enrollment
40
Registered
2016-08-29
Start date
2011-08-31
Completion date
2014-09-30
Last updated
2016-12-26

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

Conditions

Knee Injuries

Keywords

Analgesia, Nerve Block, Pain, Postoperative

Brief summary

Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia and postoperative bleeding from intrathecal morphine with the continuous femoral and a single-shot sciatic nerve blockades.

Detailed description

This study aims to compare intrathecal morphine as a technique for analgesia with the femoral nerve blockade associated with a single-shot sciatic nerve blockade. Analgesic efficacy, the incidence of adverse effects, and postoperative bleeding were evaluated

Interventions

PROCEDUREfemoral nerve blockade

femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery

PROCEDUREmorphine

Intrathecal morphine injection

Sponsors

University of Sao Paulo General Hospital
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
Yes

Inclusion criteria

* Patients aged over 18 years old, American Society of Anesthesiologists (ASA) physical status from I to III who underwent total knee arthroplasty

Exclusion criteria

* Patients aged below 18 years old, ASA IV or V physical status, infection near the puncture site, coagulation disorders, preexisting neurological disorders, allergy report to local anesthetics, pregnancy and lactation, contraindications to spinal block and refusal to sign an informed consent form

Design outcomes

Primary

MeasureTime frameDescription
Analgesic Efficacybaseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hoursPain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).

Secondary

MeasureTime frameDescription
Postoperative Bleedingbaseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hoursPostoperative bleeding volume (ml)

Participant flow

Participants by arm

ArmCount
Femoral Blockade
femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery
19
Morphine
intrathecal morphine morphine: Intrathecal morphine injection
20
Total39

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10

Baseline characteristics

CharacteristicFemoral BlockadeMorphineTotal
Age, Continuous67.3 years
STANDARD_DEVIATION 8.3
58.3 years
STANDARD_DEVIATION 10.5
62.5 years
STANDARD_DEVIATION 10.3
Gender
Female
16 Participants14 Participants30 Participants
Gender
Male
3 Participants6 Participants9 Participants
Weight70.7 kg
STANDARD_DEVIATION 20
77.5 kg
STANDARD_DEVIATION 16.9
76.6 kg
STANDARD_DEVIATION 14.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 190 / 20
serious
Total, serious adverse events
0 / 190 / 20

Outcome results

Primary

Analgesic Efficacy

Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).

Time frame: baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

ArmMeasureGroupValue (MEAN)Dispersion
Femoral BlockadeAnalgesic EfficacyZero hour (discharge of PACU)0 units on a scaleStandard Deviation 0
Femoral BlockadeAnalgesic Efficacy24 hours0.6 units on a scaleStandard Deviation 0.2
Femoral BlockadeAnalgesic Efficacy48 hours0.3 units on a scaleStandard Deviation 0.1
Femoral BlockadeAnalgesic Efficacy72 hours0.1 units on a scaleStandard Deviation 0.1
MorphineAnalgesic Efficacy72 hours2.6 units on a scaleStandard Deviation 0.3
MorphineAnalgesic EfficacyZero hour (discharge of PACU)0.1 units on a scaleStandard Deviation 0.1
MorphineAnalgesic Efficacy48 hours3.5 units on a scaleStandard Deviation 0.4
MorphineAnalgesic Efficacy24 hours3.0 units on a scaleStandard Deviation 0.5
Comparison: Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groupsp-value: <0.05ANOVA
Secondary

Postoperative Bleeding

Postoperative bleeding volume (ml)

Time frame: baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

ArmMeasureGroupValue (MEAN)Dispersion
Femoral BlockadePostoperative Bleeding72 hours20.0 mLStandard Deviation 0
Femoral BlockadePostoperative Bleeding24 hours180.5 mLStandard Deviation 19.7
Femoral BlockadePostoperative BleedingZero hour (discharge of PACU)136.5 mLStandard Deviation 20.5
Femoral BlockadePostoperative Bleeding48 hours69.2 mLStandard Deviation 20.7
MorphinePostoperative BleedingZero hour (discharge of PACU)271.8 mLStandard Deviation 33.3
MorphinePostoperative Bleeding72 hours155.3 mLStandard Deviation 39.1
MorphinePostoperative Bleeding48 hours111.9 mLStandard Deviation 28.4
MorphinePostoperative Bleeding24 hours334.7 mLStandard Deviation 39.6
Comparison: Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groupsp-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026