Trial Outcomes & Findings for Methadone and Hydromorphone For Spinal Surgery (NCT NCT02107339)

NCT ID: NCT02107339

Last Updated: 2019-09-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: Use of hydromorphone at 24 hours
• Results posted on: 2019-09-30

Participant Flow

Participant milestones

Measure	Methadone Group Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Overall Study STARTED	63	57
Overall Study COMPLETED	62	53
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methadone and Hydromorphone For Spinal Surgery

Baseline characteristics by cohort

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia	Total n=115 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	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Age, Continuous	64.5 years n=5 Participants	60 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	21 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	53 participants n=7 Participants	115 participants n=5 Participants

PRIMARY outcome

Timeframe: Use of hydromorphone at 24 hours

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Hydromorphone Use at 24 Hours	4.56 milligrams Interval 2.3 to 7.1	9.9 milligrams Interval 6.45 to 13.2

SECONDARY outcome

Timeframe: 24-48 hours after surgery

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Hydromorphone Use Second 24 Hours	0.6 milligrams Interval 0.0 to 2.8	3.15 milligrams Interval 0.75 to 8.2

SECONDARY outcome

Timeframe: 48-72 hours after surgery

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Hydromorphone Use Third 24 Hours	0 milligrams Interval 0.0 to 0.05	0.35 milligrams Interval 0.0 to 3.4

SECONDARY outcome

Timeframe: First 5 minutes after PACU arrival

11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Pain Scores Postanesthesia Care Unit (PACU) Arrival	5 units on a scale Interval 1.0 to 7.0	8 units on a scale Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: Pain scores at 60 minutes after PACU admission

11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Pain Scores 1 Hour After PACU Arrival	4 units on a scale Interval 3.0 to 6.0	6 units on a scale Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: Pain scores at 120 minutes after PACU admission

11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Pain Scores 2 Hours After PACU Arrival	4 units on a scale Interval 2.0 to 4.0	6 units on a scale Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: Pain scores one day after PACU admission

11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Pain Scores on Postoperative Day One	4 units on a scale Interval 2.0 to 5.0	5 units on a scale Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: Pain scores 48 hours after PACU admission

11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Pain Scores on Postoperative Day 2	4.56 units on a scale Interval 2.0 to 5.0	6 units on a scale Interval 3.5 to 8.0

SECONDARY outcome

Timeframe: Pain scores 72 hours after PACU admission

11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Pain Scores Postoperative Day 3	4 units on a scale Interval 2.0 to 5.0	5 units on a scale Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: Postopertive day 1

Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Patient Satisfaction Scores	92.5 units on a scale Interval 85.0 to 100.0	80 units on a scale Interval 70.0 to 90.0

SECONDARY outcome

Timeframe: postoperative day 2

Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Patient Satisfaction Scores	90 units on a scale Interval 85.0 to 100.0	82.5 units on a scale Interval 70.0 to 90.0

SECONDARY outcome

Timeframe: Postoperative day 3

Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))

Outcome measures

Measure	Methadone Group n=62 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=53 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Patient Satisfaction Scores	95 units on a scale Interval 90.0 to 100.0	90 units on a scale Interval 77.5 to 95.0

SECONDARY outcome

Timeframe: One month after surgery

Population: A home postal survey was sent to participants in the clinical trial 1 month after surgery. 41 patients in the methadone group and 34 patients in the hydromorphone group returned the surveys

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Measure	Methadone Group n=41 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=34 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Chronic Persistent Surgical Pain-Weekly Frequency of Pain	2 score on a scale Interval 1.0 to 3.0	3 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 3 months after surgery

Population: A home postal survey was sent to participants in the clinical trial 3 months after surgery. 38 patients in the methadone group and 27 patients in the hydromorphone group returned the surveys.

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Measure	Methadone Group n=38 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=27 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Chronic Persistent Surgical Pain-weekly Frequency of Pain	0 score on a scale Interval 0.0 to 3.0	3 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 6 months after surgery

Population: A home postal survey was sent to participants in the clinical trial 6 months after surgery. 24 patients in the methadone group and 32 patients in the hydromorphone group returned the surveys

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Measure	Methadone Group n=24 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=32 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Chronic Persistent Surgical Pain-Weekly Frequency of Pain	0 score on a scale Interval 0.0 to 3.0	2 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 12 months after surgery

Population: A home postal survey was sent to participants in the clinical trial 12 months after surgery. 39 patients in the methadone group and 40 patients in the hydromorphone group returned the surveys

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Measure	Methadone Group n=39 Participants Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose) Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia	Hydromorphone Group n=40 Participants Patients will receive hydromorphone 2 mg at the end of the surgical procedure Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Chronic Persistent Surgical Pain-Weekly Frequency of Pain	0 score on a scale Interval 0.0 to 2.0	2 score on a scale Interval 0.0 to 3.0

Adverse Events

Methadone Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hydromorphone Group

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

Glenn Murphy

NorthShore University HealthSystem

Phone: 847-570-2760

Email: dgmurphy2@yahoo.com

Results disclosure agreements

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