Postoperatory Analgesia After Total Knee Arthroplasty

NCT ID: NCT01700517

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-10-31

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.

Conditions

PAIN

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Spinal anesthesia

Intervention Type: OTHER

spinal anesthesia

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.

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: OTHER

spinal anesthesia

Femoral nerve block

Intervention Type: OTHER

Femoral nerve block

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.

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: OTHER

spinal anesthesia

Femoral nerve block

Intervention Type: OTHER

Femoral nerve block

sciatic nerves block

Intervention Type: OTHER

sciatic nerves block

Interventions

Spinal anesthesia

spinal anesthesia

Intervention Type: OTHER

Femoral nerve block

Femoral nerve block

Intervention Type: OTHER

sciatic nerves block

sciatic nerves block

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Madre Teresa

OTHER

Sponsor Role: lead

Responsible Party

Lucio Honorio de Carvalho Junior, PhD, PrincipalInvestigator

PhD, COORDINATOR OF KNEE SURGERY GROUP, ASSOCIATED PROFESSOR, PRINCIPAL INVESTIGATOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LUCIO H CARVALHO, PhD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL MADRE TERESA - UNIVERSIDADE FEDERAL DE MINAS GERAIS

EDUARDO F TEMPONI, MD

Role: STUDY_DIRECTOR

MADRE TERESA´S HOSPITAL

Locations

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

TKR-PAIN CONTROL

Identifier Type: -

Identifier Source: org_study_id