Skip to content

Postoperatory Analgesia After Total Knee Arthroplasty

Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01700517
Acronym
PAINCONTROL
Enrollment
120
Registered
2012-10-04
Start date
2011-12-31
Completion date
2012-10-31
Last updated
2013-05-03

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

Conditions

PAIN

Keywords

total knee arthroplasty, analgesia, ultrasonography

Brief summary

Total knee arthroplasty (TKA) is a worldwide realized procedure, with 600.000 surgeries performed per year in the United States, with a 673% increase estimated until 2030. Functional and pain management improvement is expected in 90% of patients, with 85% of them satisfied after the procedure. Immediate postoperatory pain control is an important aspect to be considered. Patients submitted to TKA endure pain with variations between 40-80 (according to analog visual scale -AVS - which goes from zero to 100) during the immediate postoperatory, with slow decline in the first 24 hours. Pain classified as severe occurs in 60% and moderated in 30% of patients submitted to TKA during this period of time. Therefore adequate pain management allows an earlier rehabilitation, with a higher satisfaction rate and decrease the hospitalization period. A multimodal control of pain can be reached by using non-steroidal anti-inflammatory, COX-2 anti-inflammatory inhibitors, peripheral nerve blocks and intra-articular anesthetics injections and decrease use of opioids given of potential collateral effects. Peripheral blockings are associated to the smallest rate of collateral effects and complications when compared to the spinal anesthesia and analgesia controlled by the patients. Studies comparing the effects of the femoral and sciatic-femoral blocking guided by ultrasonography for the analgesia control after TKA were not found. The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.

Detailed description

Inclusion criteria were considered: Patients with TKA indication, aged from 40 to 90 years, weight between 50 and 100 kg, body mass index between 18 - 36 and patients classified pre-operatory according to the American Anesthesia Association as ASA I or II. Non-cooperative patients, with cognitive incapacity to answer pain VAS, neuromuscular or peripheral neuropathies, chronically using opioid or who didn´t want to take part of the study were taken as exclusion criteria. The patients were separated in three groups at randomized by a computer program: Group A - control group - spinal anesthesia, Group B - femoral nerve block + procedure realized in group A and Group C - femoral and sciatic nerves block + procedure realized in group A. All the anesthetics procedures were realized by the same anesthetist. The standard anesthesia for the procedure was spinal anesthesia with injection of 12 to 15 mg of 0.5% isobaric bupivacaine. Patients of the control group (group A) were submitted to spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication. The patients of the group B received, furthermore the standard anesthesia, the block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine. For the patients of the group C, in addition to the femoral blocking, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine. As an adjuvant for analgesia, all the patients received analgesic and anti-inflammatory permanently in postoperatory, with availability of opioids for rescue if needed. The necessity of its use and eventual complications were registered until hospital discharge. The pain measurement was realized by the assistant author using a 10 points pain AVS (0, absence of pain, and 10 the worst imaginable pain) both ignoring which group the patient was part of. This measurement was realized during immediate pre-operatory, within 6, 12, 24, 48 hours after surgery. Details of this study were approved by the Ethical Committee and written informed consent was obtained from each participant prior to the commencement of the study.

Interventions

OTHERSpinal anesthesia

spinal anesthesia

OTHERFemoral nerve block

Femoral nerve block

OTHERsciatic nerves block

sciatic nerves block

Sponsors

Hospital Madre Teresa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Inclusion criteria were considered: Patients with TKA indication, aged from 40 to 90 years, weight between 50 and 100 kg, body mass index between 18 - 36 and patients classified pre-operatory according to the American Anesthesia Association as ASA I or II.

Exclusion criteria

* Non-cooperative patients, with cognitive incapacity to answer pain VAS, neuromuscular or peripheral neuropathies, chronically using opioid or who didn´t want to take part of the study were taken as

Design outcomes

Primary

MeasureTime frameDescription
Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block48 HOURSThe objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures. To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.

Countries

Brazil

Participant flow

Recruitment details

120 patients submitted to TKA in Madre Teresa´s Hospital between 2011 and 2012 by three authors were enrolled in this prospective, randomized, placebo controlled and double-blinded study after receiving three different types of anesthesia.

Pre-assignment details

Non-cooperative patients, with cognitive incapacity to understand the AVS, neuromuscular or peripheral neuropathies, chronicle use of opioids or the ones who didn´t want to take part of the study were excluded.

Participants by arm

ArmCount
Femoral Nerve Block
In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine. Spinal anesthesia : spinal anesthesia Femoral nerve block : Femoral nerve block
40
Control Group
Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication. Spinal anesthesia : spinal anesthesia
40
Sciatic Nerves Block
In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine. sciatic nerves block : sciatic nerves block Spinal anesthesia : spinal anesthesia Femoral nerve block : Femoral nerve block
40
Total120

Baseline characteristics

CharacteristicSciatic Nerves BlockTotalFemoral Nerve BlockControl Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
31 Participants99 Participants32 Participants36 Participants
Age, Categorical
Between 18 and 65 years
9 Participants21 Participants8 Participants4 Participants
Age Continuous71.8 years
STANDARD_DEVIATION 7
71.9 years
STANDARD_DEVIATION 7.8
72 years
STANDARD_DEVIATION 8.8
71.9 years
STANDARD_DEVIATION 8
Region of Enrollment
Brazil
40 participants120 participants40 participants40 participants
Sex: Female, Male
Female
34 Participants94 Participants28 Participants32 Participants
Sex: Female, Male
Male
6 Participants26 Participants12 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 400 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 400 / 40

Outcome results

Primary

Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block

The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures. To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.

Time frame: 48 HOURS

Population: This sample size was calculated for a fixed effects one-way analysis of variance design. It was assumed that the standard effect size (d) = 0.5, the level of alpha (two-tailed) = 0.05, and power = 0.8, resulting in twenty six patient. The sample was stratified, having 40 patients in each of three groups to compensate for expected dropouts

ArmMeasureValue (MEAN)
Femoral Nerve BlockPostoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block2 units on a scale
Control GroupPostoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block2.8 units on a scale
Sciatic Nerves BlockPostoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block1.5 units on a scale

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