Trial Outcomes & Findings for Lumbar Plexus Block vs Fascia Iliaca Block After Hip Arthroscopy (NCT NCT02882633)

NCT ID: NCT02882633

Last Updated: 2019-06-11

Results Overview

Change in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Change from baseline through 15 minutes
• Results posted on: 2019-06-11

Participant Flow

Participant milestones

Measure	Lumbar Plexus Block Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Fascia Iliac Block Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
Overall Study STARTED	25	25
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Lumbar Plexus Block n=23 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Fascia Iliaca Block n=25 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Total n=48 Participants Total of all reporting groups
Age, Continuous	38.83 years STANDARD_DEVIATION 11.55 • n=23 Participants	39.8 years STANDARD_DEVIATION 11.40 • n=25 Participants	39.34 years STANDARD_DEVIATION 11.36 • n=48 Participants
Sex: Female, Male Female	16 Participants n=23 Participants	16 Participants n=25 Participants	32 Participants n=48 Participants
Sex: Female, Male Male	7 Participants n=23 Participants	9 Participants n=25 Participants	16 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index	29.89 kg/m^2 STANDARD_DEVIATION 6.59 • n=23 Participants	26.80 kg/m^2 STANDARD_DEVIATION 4.52 • n=25 Participants	28.28 kg/m^2 STANDARD_DEVIATION 5.76 • n=48 Participants
Femoral/Acetabular osteoplasty	19 Participants n=23 Participants	23 Participants n=25 Participants	42 Participants n=48 Participants
Peri-trochanteric space surgery	4 Participants n=23 Participants	2 Participants n=25 Participants	6 Participants n=48 Participants

PRIMARY outcome

Timeframe: Change from baseline through 15 minutes

Change in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.

Outcome measures

Measure	Lumbar Plexus Block n=23 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Fascia Iliac Block n=25 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
Pain Score Change	3 change in score on a scale Interval 1.0 to 3.0	1.72 change in score on a scale Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: While in PACU. An average length of stay for Lumbar Plexus Block group was 165.04 min and 139.72 min for Fascia Iliaca Block group.

Participants need for pain relief as measured by opiate consumption

Outcome measures

Measure	Lumbar Plexus Block n=23 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Fascia Iliac Block n=25 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
Amount of Opiate Consumption	16.98 mg Interval 5.81 to 22.5	20.80 mg Interval 5.62 to 33.75

SECONDARY outcome

Timeframe: Change from baseline through 24 hours

Score of QoR survey to determine recovery status. 0-18 where 0 is the worst and 18 is the best feeling.

Outcome measures

Measure	Lumbar Plexus Block n=23 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Fascia Iliac Block n=25 Participants Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
Quality of Recovery	14.52 Score on a scale Interval 14.0 to 17.0	15.91 Score on a scale Interval 11.0 to 18.0

Adverse Events

Lumbar Plexus Block

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Fascia Iliac Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lumbar Plexus Block n=23 participants at risk Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Fascia Iliac Block n=25 participants at risk Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
Surgical and medical procedures Epidural Spread	4.3% 1/23 • Number of events 1 • Adverse Effects data collected day of procedure and following 48 hours	0.00% 0/25 • Adverse Effects data collected day of procedure and following 48 hours

Other adverse events

Measure	Lumbar Plexus Block n=23 participants at risk Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic	Fascia Iliac Block n=25 participants at risk Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain 30ml bolus of bupivacaine: Local anesthetic
Surgical and medical procedures Epidural Spread	4.3% 1/23 • Number of events 1 • Adverse Effects data collected day of procedure and following 48 hours	0.00% 0/25 • Adverse Effects data collected day of procedure and following 48 hours

Additional Information

Ignacio Badiola

University of Pennsylvania

Phone: 215-893-7251

Email: Ignacio.Badiola@uphs.upenn.edu

Results disclosure agreements

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