Postoperatory Analgesia After Total Knee Arthroplasty (PAINCONTROL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lucio Honorio de Carvalho Junior, PhD, PrincipalInvestigator, Hospital Madre Teresa
ClinicalTrials.gov Identifier:
NCT01700517
First received: September 25, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
PAIN
Other: Spinal anesthesia
Other: Femoral nerve block
Other: sciatic nerves block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block

Resource links provided by NLM:


Further study details as provided by Hospital Madre Teresa:

Primary Outcome Measures:
  • Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block [ Time Frame: 48 HOURS ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 120
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 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.
Other: Spinal anesthesia
spinal anesthesia
Other Name: Spinal anesthesia
Experimental: 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.
Other: Spinal anesthesia
spinal anesthesia
Other Name: Spinal anesthesia
Other: Femoral nerve block
Femoral nerve block
Other Name: Femoral nerve block
Experimental: 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.
Other: Spinal anesthesia
spinal anesthesia
Other Name: Spinal anesthesia
Other: Femoral nerve block
Femoral nerve block
Other Name: Femoral nerve block
Other: sciatic nerves block
sciatic nerves block
Other Name: sciatic nerves block

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

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01700517

Locations
Brazil
Hospital Madre Teresa
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Hospital Madre Teresa
Investigators
Principal Investigator: LUCIO H CARVALHO, PhD HOSPITAL MADRE TERESA - UNIVERSIDADE FEDERAL DE MINAS GERAIS
Study Director: EDUARDO F TEMPONI, MD MADRE TERESA´S HOSPITAL
  More Information

No publications provided

Responsible Party: Lucio Honorio de Carvalho Junior, PhD, PrincipalInvestigator, PhD, COORDINATOR OF KNEE SURGERY GROUP, ASSOCIATED PROFESSOR, PRINCIPAL INVESTIGATOR, Hospital Madre Teresa
ClinicalTrials.gov Identifier: NCT01700517     History of Changes
Other Study ID Numbers: TKR-PAIN CONTROL
Study First Received: September 25, 2012
Results First Received: October 21, 2012
Last Updated: March 19, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Madre Teresa:
total knee arthroplasty, analgesia, ultrasonography

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014