Trial Outcomes & Findings for Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty (NCT NCT02933671)

NCT ID: NCT02933671

Last Updated: 2022-07-19

Results Overview

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 4 hours postoperatively
• Results posted on: 2022-07-19

Participant Flow

Participant milestones

Measure	Suprainguinal Fascia Iliaca (SIFI) Block A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty

Baseline characteristics by cohort

Measure	Suprainguinal Fascia Iliaca (SIFI) Block n=5 Participants A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group n=5 Participants The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo	Total n=10 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 6.0 • n=5 Participants	51.6 years STANDARD_DEVIATION 17.8 • n=7 Participants	57.7 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours postoperatively

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

Outcome measures

Measure	Suprainguinal Fascia Iliaca (SIFI) Block n=5 Participants A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group n=5 Participants The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11	2.4 score on a scale Standard Deviation 1.14	5.4 score on a scale Standard Deviation 1.95

SECONDARY outcome

Timeframe: 24 hours

Reported in IV morphine equivalents.

Outcome measures

Measure	Suprainguinal Fascia Iliaca (SIFI) Block n=5 Participants A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group n=5 Participants The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo
Cumulative Opioid Consumption	33.8 IV morphine equivalents in mg Standard Deviation 24.0	41.9 IV morphine equivalents in mg Standard Deviation 29.3

SECONDARY outcome

Timeframe: 4 hours postoperatively

Reported as pounds per square inch (PSI).

Outcome measures

Measure	Suprainguinal Fascia Iliaca (SIFI) Block n=5 Participants A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group n=5 Participants The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo
Motor Strength, as Measured by Dynamometry	28.7 PSI Standard Deviation 14.8	19.7 PSI Standard Deviation 22.8

SECONDARY outcome

Timeframe: 24 hours

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

Outcome measures

Measure	Suprainguinal Fascia Iliaca (SIFI) Block n=5 Participants A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group n=5 Participants The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo
Numeric Pain Score at 24 Hours, as Measured by NRS 11	2.6 score on a scale Standard Deviation 1.9	5.2 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: post-op day 0

Outcome measures

Measure	Suprainguinal Fascia Iliaca (SIFI) Block n=5 Participants A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group n=5 Participants The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo
Ambulation, as Measured by Distanced Walked	99.6 feet Standard Deviation 122.2	20.8 feet Standard Deviation 44.3

Adverse Events

Suprainguinal Fascia Iliaca (SIFI) Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Suprainguinal Fascia Iliaca (SIFI) Block n=5 participants at risk A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug)	Sham Group n=5 participants at risk The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo
Musculoskeletal and connective tissue disorders Motor weakness in the quadriceps and adductor group muscles	0.00% 0/5 • 24 hours from time of block	20.0% 1/5 • 24 hours from time of block

Additional Information

W. Michael Bullock, MD, PhD

Duke University

Phone: 919-668-2024

Email: william.bullock@duke.edu

Results disclosure agreements

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