Trial Outcomes & Findings for Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing (NCT NCT00934661)

NCT ID: NCT00934661

Last Updated: 2018-09-12

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: From surgery day to hospital discharge, up to 4 days
• Results posted on: 2018-09-12

Participant Flow

Participant milestones

Measure	Extended Release Epidural Morphine Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Extended Release Epidural Morphine Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Overall Study Failure of Combined/Spinal Epidural	1	0

Baseline Characteristics

Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing

Baseline characteristics by cohort

Measure	Extended Release Epidural Morphine n=19 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=20 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: From surgery day to hospital discharge, up to 4 days

Outcome measures

Measure	Extended Release Epidural Morphine n=19 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=20 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Length of Hospital Stay After Surgery	2.26 Days Standard Deviation 1.29	2.51 Days Standard Deviation 2.02

SECONDARY outcome

Timeframe: 96 hours

Population: Data not collected on Extended Release Epidural Morphine group

Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.)

Outcome measures

Measure	Extended Release Epidural Morphine Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=20 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Total Opioid Consumption	—	10.5 mg Standard Deviation 1.8

SECONDARY outcome

Timeframe: 96 hours

Population: 17 participants in the Extended Release Epidural Morphine group and 18 participants in the placebo group provided Verbal satisfaction scores

Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.

Outcome measures

Measure	Extended Release Epidural Morphine n=17 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=18 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Patient Satisfaction Score Total Mean and Standard Deviation	9.03 units on a scale Standard Deviation 1.46	8.58 units on a scale Standard Deviation 1.49
Patient Satisfaction Score Post Day 1 Surgery	9.12 units on a scale Standard Deviation 1.73	8.53 units on a scale Standard Deviation 1.28
Patient Satisfaction Score Post Day 2 Surgery	8.76 units on a scale Standard Deviation 1.68	8.94 units on a scale Standard Deviation 1.29
Patient Satisfaction Score Post Day 3 Surgery	9.06 units on a scale Standard Deviation 1.20	8.33 units on a scale Standard Deviation 1.57
Patient Satisfaction Score Post Day 4 Surgery	9.18 units on a scale Standard Deviation 1.24	8.56 units on a scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: 96 hours

Population: Different amount of observations were different at each visit. Data for Post Surgery Day 4 for the "Extended Release Epidural Morphine" was not collected.

Distance walked at walking test. Longer distance walked represent better outcomes

Outcome measures

Measure	Extended Release Epidural Morphine n=18 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=20 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Distance Walked at Walking Test Post Surgery Day 2	206.7 Steps Standard Deviation 97.1	143.5 Steps Standard Deviation 97.4
Distance Walked at Walking Test Post Surgery Day 3	200.0 Steps Standard Deviation 70.7	175.0 Steps Standard Deviation 132.8
Distance Walked at Walking Test Post Surgery Day 4	—	100.0 Steps Standard Deviation 141.2
Distance Walked at Walking Test Post Surgery Day 1	168.1 Steps Standard Deviation 164.2	109.8 Steps Standard Deviation 117.9

SECONDARY outcome

Timeframe: 1 day post surgery

Population: 16 participants were analyzed in both the Extended Release Epidural Morphine and the Placebo Group for active pain scores. 17 participants overall were analyzed for the Extended Release Epidural Morphine and 18 participants overall were analyzed for the Placebo Group.

Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.

Outcome measures

Measure	Extended Release Epidural Morphine n=17 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=18 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Verbal Pain Scores Post-gait Pain Score Active	3.44 units on a scale Standard Deviation 2.94	7.16 units on a scale Standard Deviation 2.13
Verbal Pain Scores Post-gait Pain Score at Rest	2.35 units on a scale Standard Deviation 2.5	3.58 units on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: 2 Days Post Surgery

Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.

Outcome measures

Measure	Extended Release Epidural Morphine n=17 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=17 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Verbal Pain Scores Post-gait Pain Score Active	5.29 units on a scale Standard Deviation 2.23	5.24 units on a scale Standard Deviation 2.28
Verbal Pain Scores Post-gait Pain Score at Rest	2.35 units on a scale Standard Deviation 1.41	2.41 units on a scale Standard Deviation 1.58

SECONDARY outcome

Timeframe: 3 Days Post Surgery

Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.

Outcome measures

Measure	Extended Release Epidural Morphine n=17 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=18 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Verbal Pain Scores Post-gait Pain Score Active	4.18 units on a scale Standard Deviation 2.48	5.06 units on a scale Standard Deviation 2.29
Verbal Pain Scores Post-gait Pain Score at Rest	2.59 units on a scale Standard Deviation 2.29	2.78 units on a scale Standard Deviation 2.05

SECONDARY outcome

Timeframe: 4 Days Post Surgery

Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.

Outcome measures

Measure	Extended Release Epidural Morphine n=17 Participants Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=16 Participants The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Verbal Pain Scores Post-gait Pain Score Active	3.59 units on a scale Standard Deviation 2.15	5.00 units on a scale Standard Deviation 2.56
Verbal Pain Scores Post-gait Pain Score at Rest	1.88 units on a scale Standard Deviation 2.26	2.94 units on a scale Standard Deviation 2.32

Adverse Events

Extended Release Epidural Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo 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	Extended Release Epidural Morphine n=20 participants at risk Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline	Placebo Group n=20 participants at risk The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Blood and lymphatic system disorders Hypotension	0.00% 0/20	5.0% 1/20 • Number of events 1

Additional Information

Dr. Pamela Nagle Assistant Professor

Anesthesiology

Phone: 336-716-7180

Results disclosure agreements

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