Postoperatory Analgesia After Total Knee Arthroplasty

NCT01700517 | Completed Results DMC

• 1 other identifier: TKR-PAIN CONTROL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

PAIN

Keywords

total knee arthroplasty, analgesia, ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  48 HOURS

Study Arms (3)

control group

SHAM COMPARATOR

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.

Other: Spinal anesthesia

Femoral nerve block

EXPERIMENTAL

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.

Other: Spinal anesthesia; Other: Femoral nerve block

sciatic nerves block

EXPERIMENTAL

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.

Other: Spinal anesthesia; Other: Femoral nerve block; Other: sciatic nerves block

Interventions

Spinal anesthesia OTHER

spinal anesthesia

Femoral nerve block; control group; sciatic nerves block

Femoral nerve block OTHER

Femoral nerve block

Femoral nerve block; sciatic nerves block

sciatic nerves block OTHER

sciatic nerves block

sciatic nerves block

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital Madre Teresa: lead

Study Sites (1)

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Limitations and Caveats

The relative small sample size is one of them. Differences between groups are expected to grow as sample size increases. Despite an improvement in pain control with femoral and sciatic femoral blocks, the morphine consumption was not reduced.

Results Point of Contact

• Title: Dr Lucio Honorio de Carvalho Júnior
• Organization: Madre Teresa´s Hospital

luciohcj@gmail.com

+55 31 33398000

Study Officials

• LUCIO H CARVALHO, PhD

  HOSPITAL MADRE TERESA - UNIVERSIDADE FEDERAL DE MINAS GERAIS

  PRINCIPAL INVESTIGATOR

• EDUARDO F TEMPONI, MD

  MADRE TERESA´S HOSPITAL

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, COORDINATOR OF KNEE SURGERY GROUP, ASSOCIATED PROFESSOR, PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 4, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 3, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-03

Locations

BR (1)