Clinical trial NCT01700517: Postoperatory Analgesia After Total Knee Arthroplasty
Official title: Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PAIN
Keywords: total knee arthroplasty, analgesia, ultrasonography
Lead sponsor: Hospital Madre Teresa
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 exclusion criteria.

Primary outcomes:
measure: Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block
timeFrame: 48 HOURS
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital Madre Teresa
state: Minas Gerais
Study officials:
affiliation: HOSPITAL MADRE TERESA - UNIVERSIDADE FEDERAL DE MINAS GERAIS
name: LUCIO H CARVALHO, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MADRE TERESA´S HOSPITAL
name: EDUARDO F TEMPONI, MD
role: STUDY_DIRECTOR
References: