Trial Outcomes & Findings for Postoperatory Analgesia After Total Knee Arthroplasty (NCT NCT01700517)

Last Updated: 2013-05-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

48 HOURS

Results posted on

2013-05-03

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	40	40	40
Overall Study COMPLETED	40	40	40
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postoperatory Analgesia After Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Femoral Nerve Block n=40 Participants 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	Control Group n=40 Participants 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	Sciatic Nerves Block n=40 Participants 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	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	36 Participants n=7 Participants	31 Participants n=5 Participants	99 Participants n=4 Participants
Age Continuous	72 years STANDARD_DEVIATION 8.8 • n=5 Participants	71.9 years STANDARD_DEVIATION 8 • n=7 Participants	71.8 years STANDARD_DEVIATION 7 • n=5 Participants	71.9 years STANDARD_DEVIATION 7.8 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	32 Participants n=7 Participants	34 Participants n=5 Participants	94 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Region of Enrollment Brazil	40 participants n=5 Participants	40 participants n=7 Participants	40 participants n=5 Participants	120 participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=40 Participants 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 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.	Control Group n=40 Participants 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 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.	Sciatic Nerves Block n=40 Participants 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 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.
Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block	2 units on a scale Interval 0.0 to 10.0	2.8 units on a scale Interval 0.0 to 10.0	1.5 units on a scale Interval 0.0 to 10.0

Adverse Events

Femoral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sciatic Nerves Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Lucio Honorio de Carvalho Júnior

Madre Teresa´s Hospital

Phone: +55 31 33398000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place