Unique ID issued by UMIN | UMIN000013364 |
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Receipt number | R000015591 |
Scientific Title | A prospective, single-center randomised double-blinded parallel-group comparison study of the postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty |
Date of disclosure of the study information | 2014/03/07 |
Last modified on | 2014/05/25 12:26:41 |
A prospective, single-center randomised double-blinded parallel-group comparison study of the postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty
Postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty
A prospective, single-center randomised double-blinded parallel-group comparison study of the postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty
Postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty
Japan |
Degenerative arthritis
Orthopedics |
Others
NO
Compare the postoperative analgesic effect of local anaesthetic infiltration with that of sciatic nerve block in combination with a continuous femoral nerve block after total knee arthroplasty.
Efficacy
Comparison of changes in Numerical Rating Scale (NRS) between local anaesthetic infiltration and sciatic nerve block at five time points; on exiting the operating room and 3, 6, 12, 24 hour later.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Maneuver |
Subjects were administered a 20-ml bolus injection of 0.375% ropivacaine for a femoral nerve block and catheter were inserted for a continuous femoral nerve block after the insertion of a laryngeal airway in combination with a nerve stimulus. The local anaesthetic mixture (100 ml of 0.2% ropivacaine by adding 0.5 mg of adrenaline) was administered three times in divided doses during operation. A continuous femoral block of 0.2% ropivacaine 5 ml h-1 was commenced at the end of the operation.
The participants were administered a 25-mg diclofenac suppository if the NRS was >3 upon exiting the operating room and at 3, 6, 12, and 24 h after that time or at any other time they requested an analgesic with an NRS greater than 3. The participants had received an explanation that the number, 0, on a ruler represented the absence of pain and the number, 10, represented the most severe pain they had ever felt and were asked to point to the number that best estimated their pain on the scale (NRS). Repeated administrations of a 25-mg diclofenac suppository were allowed after a 3-h interval. If this method was inadequate and the patient could not cope with the pain (NRS, >3), 15 mg of pentazocine was injected intramuscularly.
Nurses in the operating room and on the ward who were blinded to the group allocations recorded the NRS.
Subjects were moved to a lateral recumbent position after insertion of a laryngeal airway and administered a 20-ml bolus injection of 0.375% ropivacaine for a sciatic nerve block. After a sciatic nerve block, the patients were moved into a supine position and administered a 20-ml bolus injection of 0.375% ropivacaine for a femoral nerve block and catheter was inserted for a continuous femoral nerve block. A continuous femoral nerve block of 0.2% ropivacaine 5 ml h-1 was commenced at the end of the operation.
The participants were administered a 25-mg diclofenac suppository if the NRS was >3 upon exiting the operating room and at 3, 6, 12, and 24 h after that time or at any other time they requested an analgesic with an NRS greater than 3. The participants had received an explanation that the number, 0, on a ruler represented the absence of pain and the number, 10, represented the most severe pain they had ever felt and were asked to point to the number that best estimated their pain on the scale (NRS). Repeated administrations of a 25-mg diclofenac suppository were allowed after a 3-h interval. If this method was inadequate and the patient could not cope with the pain (NRS, >3), 15 mg of pentazocine was injected intramuscularly.
Nurses in the operating room and on the ward who were blinded to the group allocations recorded the NRS.
Not applicable |
Not applicable |
Male and Female
 TKA for degenerative arthritis
 American Society of Anesthesiologists physical status, 1–3
 Weight, 40–99 kg
 Fully understood the study contents from oral and written descriptions
 Bilateral TKA
 Regular narcotic users
 Allergy to any study drug
 Neuromuscular disease
 Sensory disturbances of the leg
 Severe diabetes
 Heart failure (AHA >3)
 Renal impairment with an estimated glomerular filtration rate of <60 mL min-1 1.73 m-2,
 Liver dysfunction (Child–Pugh > B)
 Impossible to assess using the numeric rating scale (NRS)
34
1st name | |
Middle name | |
Last name | Junya Oshida |
Saitama City Hospital
Department of Anesthesiology
Mimuro 2460, Saitama Midori-ku, Saitama, 336-8522 Japan
048-873-4111
oswillkommen@ybb.ne.jp
1st name | |
Middle name | |
Last name | Tomoyuki Sato |
Saitama City Hospital
Department of Intensive Care
Mimuro 2460, Saitama Midori-ku, Saitama, 336-8522 Japan
048-873-4111
tomoyukisatoh@seagreen.ocn.ne.jp
Saitama City Hospital
None
Self funding
NO
さいたま市立病院(埼玉県)
2014 | Year | 03 | Month | 07 | Day |
Unpublished
Completed
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2013 | Year | 06 | Month | 30 | Day |
2013 | Year | 09 | Month | 30 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 01 | Month | 15 | Day |
2014 | Year | 03 | Month | 07 | Day |
2014 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015591
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