Trial Outcomes & Findings for Compare Epidural vs. Lumbar Plexus Analgesia After Hip Arthroplasty (NCT NCT02493621)

NCT ID: NCT02493621

Last Updated: 2019-03-22

Results Overview

Cumulative opiate consumption in intravenous (IV) morphine mg equivalents (MME)

• Recruitment status: COMPLETED
• Target enrollment: 116 participants
• Primary outcome timeframe: 48 hours postoperative
• Results posted on: 2019-03-22

Participant Flow

Inclusion criteria included primary, elective THA with either lumbar epidural (n=547) or lumbar plexus peripheral nerve block (n=219) for postoperative analgesia. Exclusion criteria included THA revision, traumatic fractures, non-elective surgeries, and postoperative ICU admission. 342 epidural &107 lumbar plexus patients met inclusion criteria.

Subjects meeting inclusion criteria were assigned a chronological number based on the date of their operation (Epidural 1-342; Lumbar plexus 1-107) and then randomized using Microsoft Excel. Data were collected on the first 58 randomized subjects in each group; 58 epidural patients and 58 lumbar plexus patients.

Participant milestones

Measure	Lumbar Plexus Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.	Lumbar Epidural Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
Overall Study STARTED	58	58
Overall Study COMPLETED	58	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compare Epidural vs. Lumbar Plexus Analgesia After Hip Arthroplasty

Baseline characteristics by cohort

Measure	Lumbar Plexus n=58 Participants Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.	Lumbar Epidural n=58 Participants Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.	Total n=116 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 4.50 • n=5 Participants	61.3 years STANDARD_DEVIATION 1.99 • n=7 Participants	60.8 years STANDARD_DEVIATION 3.76 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	29 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	29 Participants n=7 Participants	52 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	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	45 Participants n=7 Participants	92 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	58 participants n=5 Participants	58 participants n=7 Participants	116 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours postoperative

Cumulative opiate consumption in intravenous (IV) morphine mg equivalents (MME)

Outcome measures

Measure	Lumbar Plexus n=58 Participants Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.	Lumbar Epidural n=58 Participants Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
Opiate Consumption	64.8 Opiate Consumption (IV MME) Standard Error 3.32	81.3 Opiate Consumption (IV MME) Standard Error 4.13

SECONDARY outcome

Timeframe: 48 hours

Time of first ambulation relative to anesthesia end time (hours)

Outcome measures

Measure	Lumbar Plexus n=58 Participants Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.	Lumbar Epidural n=58 Participants Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
Time of First Ambulation	24.6 Hours Standard Error 2.01	31.7 Hours Standard Error 1.54

Adverse Events

Lumbar Plexus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lumbar Epidural

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

Sylvia Wilson

MUSC

Phone: 8437922322

Email: wilsosh@musc.edu

Results disclosure agreements

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