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Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

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ClinicalTrials.gov Identifier: NCT02658240
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Irina Gasanova, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Drug: Ropivacaine
Drug: Epinephrine
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Compartment Block Infiltration
Hide Arm/Group Description

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Compartment Block Infiltration Total
Hide Arm/Group Description

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
56.2  (13.6) 59.0  (11.2) 57.6  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
18
  60.0%
18
  60.0%
36
  60.0%
Male
12
  40.0%
12
  40.0%
24
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Hispanic or Latino
12
  40.0%
11
  36.7%
23
  38.3%
Not Hispanic or Latino
18
  60.0%
19
  63.3%
37
  61.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30
 100.0%
30
 100.0%
60
 100.0%
Preoperative Pain Score at Rest   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
3
(0 to 4)
4
(3 to 6)
4
(2 to 6)
[1]
Measure Description: The Visual Analog Pain Score (VAS) on the scale of 10 (0= No pain, 10= Worst pain) at preoperatively
Preoperative Pain Score with Cough   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
4
(3 to 5)
8
(7 to 10)
8
(6.75 to 10)
[1]
Measure Description: The Visual Analog Pain Score (VAS) with cough on the scale of 10 (0= No pain, 10= Worst pain) preoperatively
1.Primary Outcome
Title Postoperative Pain Score at Resting
Hide Description The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Time Frame Postoperative 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Compartment Block Infiltration
Hide Arm/Group Description:

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Overall Number of Participants Analyzed 30 30
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(0 to 2)
2
(1 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Compartment Block, Infiltration
Comments The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Postoperative Pain Score With Movement
Hide Description The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Time Frame Postoperative 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Compartment Block Infiltration
Hide Arm/Group Description:

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Overall Number of Participants Analyzed 30 30
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(2 to 4)
4
(3 to 5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Compartment Block, Infiltration
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
Hide Description Total amounts of postoperative opioid requirements for 48 hours postoperatively
Time Frame Postoperative 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Compartment Block Infiltration
Hide Arm/Group Description:

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Oral Morphine Equivalent (mg)
101.0  (29.5) 115.6  (46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Compartment Block, Infiltration
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title The Time to Ambulation
Hide Description The time to ambulation during 48 hours postoperative period
Time Frame Postoperative 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Compartment Block Infiltration
Hide Arm/Group Description:

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Overall Number of Participants Analyzed 30 30
Median (Inter-Quartile Range)
Unit of Measure: Hours
21.3
(19 to 23.5)
22
(19.5 to 24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Compartment Block, Infiltration
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.584
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse event data were collected during 48 hours postoperatively.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Compartment Block Infiltration
Hide Arm/Group Description

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Epinephrine: 0.5 mg epinephrine

All-Cause Mortality
Compartment Block Infiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Serious Adverse Events
Compartment Block Infiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Compartment Block Infiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Irina Gasanova
Organization: UT Southwestern Medical Center
Phone: 4694191997
EMail: Irina.Gasanova@UTSouthwestern.edu
Layout table for additonal information
Responsible Party: Irina Gasanova, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02658240    
Other Study ID Numbers: STU 122015-022
First Submitted: January 14, 2016
First Posted: January 18, 2016
Results First Submitted: October 3, 2018
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018