Trial Outcomes & Findings for Femoral/Sciatic Block for Knee Surgery (NCT NCT02882152)

NCT ID: NCT02882152

Last Updated: 2016-12-26

Results Overview

Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours
• Results posted on: 2016-12-26

Participant Flow

Participant milestones

Measure	Femoral Blockade femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery	Morphine intrathecal morphine morphine: Intrathecal morphine injection
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Femoral Blockade femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery	Morphine intrathecal morphine morphine: Intrathecal morphine injection
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Femoral/Sciatic Block for Knee Surgery

Baseline characteristics by cohort

Measure	Femoral Blockade n=19 Participants femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery	Morphine n=20 Participants intrathecal morphine morphine: Intrathecal morphine injection	Total n=39 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 8.3 • n=5 Participants	58.3 years STANDARD_DEVIATION 10.5 • n=7 Participants	62.5 years STANDARD_DEVIATION 10.3 • n=5 Participants
Gender Female	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Weight	70.7 kg STANDARD_DEVIATION 20.0 • n=5 Participants	77.5 kg STANDARD_DEVIATION 16.9 • n=7 Participants	76.6 kg STANDARD_DEVIATION 14.3 • n=5 Participants

PRIMARY outcome

Timeframe: baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).

Outcome measures

Measure	Femoral Blockade n=19 Participants femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery	Morphine n=20 Participants intrathecal morphine morphine: Intrathecal morphine injection
Analgesic Efficacy Zero hour (discharge of PACU)	0 units on a scale Standard Deviation 0	0.1 units on a scale Standard Deviation 0.1
Analgesic Efficacy 24 hours	0.6 units on a scale Standard Deviation 0.2	3.0 units on a scale Standard Deviation 0.5
Analgesic Efficacy 48 hours	0.3 units on a scale Standard Deviation 0.1	3.5 units on a scale Standard Deviation 0.4
Analgesic Efficacy 72 hours	0.1 units on a scale Standard Deviation 0.1	2.6 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

Postoperative bleeding volume (ml)

Outcome measures

Measure	Femoral Blockade n=19 Participants femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery	Morphine n=20 Participants intrathecal morphine morphine: Intrathecal morphine injection
Postoperative Bleeding Zero hour (discharge of PACU)	136.5 mL Standard Deviation 20.5	271.8 mL Standard Deviation 33.3
Postoperative Bleeding 24 hours	180.5 mL Standard Deviation 19.7	334.7 mL Standard Deviation 39.6
Postoperative Bleeding 48 hours	69.2 mL Standard Deviation 20.7	111.9 mL Standard Deviation 28.4
Postoperative Bleeding 72 hours	20.0 mL Standard Deviation 0.0	155.3 mL Standard Deviation 39.1

Adverse Events

Femoral Blockade

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morphine

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. Joaquim Edson Vieira

University of São Paulo

Phone: +55 11 3061 8716

Email: joaquimev@usp.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place