Trial Outcomes & Findings for Total Hip Arthroplasty Outcomes With Regional and Multimodal Analgesia (NCT NCT02186795)

NCT ID: NCT02186795

Last Updated: 2019-03-22

Results Overview

Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)

Recruitment status

COMPLETED

Target enrollment

117 participants

Primary outcome timeframe

48 hours postoperative

Results posted on

2019-03-22

Participant Flow

Inclusion criteria consisted of primary elective THA surgery with either (1) a lumbar epidural (n = 51) or (2) a lumbar plexus peripheral nerve block (n = 312) for postoperative analgaesia. Exclusion criteria were THA revision, traumatic fractures, nonelective surgery, general anaesthesia, and post-operative intensive care unit (ICU) admission.

Of the charts reviewed, 31 lumbar epidural and 153 lumbar plexus patients met inclusion criteria and were assigned a chronological number based on the date of their operation (Epidural 1-31; Lumbar plexus 1-153). These numbered lists were then randomised and data collected on the first 24 randomised patients for each block type.

Participant milestones

Participant milestones
Measure	Lumbar Plexus Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.	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	24	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Total Hip Arthroplasty Outcomes With Regional and Multimodal Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumbar Plexus n=24 Participants Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.	Lumbar Epidural n=24 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=48 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 2.32 • n=39 Participants	61.2 years STANDARD_DEVIATION 2.55 • n=41 Participants	61.65 years STANDARD_DEVIATION 2.44 • n=35 Participants
Sex: Female, Male Female	13 Participants n=39 Participants	12 Participants n=41 Participants	25 Participants n=35 Participants
Sex: Female, Male Male	11 Participants n=39 Participants	12 Participants n=41 Participants	23 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	6 Participants n=39 Participants	1 Participants n=41 Participants	7 Participants n=35 Participants
Race (NIH/OMB) White	18 Participants n=39 Participants	23 Participants n=41 Participants	41 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants

PRIMARY outcome

Timeframe: 48 hours postoperative

Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)

Outcome measures

Outcome measures
Measure	Lumbar Plexus n=24 Participants Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.	Lumbar Epidural n=24 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	48.6 IV MME Standard Error 5.21	53.9 IV MME Standard Error 6.31

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, MD

MUSC

Phone: 843-732-2322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place