Trial Outcomes & Findings for Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients (NCT NCT02989597)

NCT ID: NCT02989597

Last Updated: 2023-05-22

Results Overview

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: Preoperatively
• Results posted on: 2023-05-22

Participant Flow

Participant milestones

Measure	Intra-operative Methadone Hydrochloride Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery Dexamethasone: Post operative swelling and pain control Ketamine: Perioperative anesthesia medication Remifentanil: Perioperative pain medication Sufentanil: Perioperative pain medication	Control Patients administered standard of care Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery Dexamethasone: Post operative swelling and pain control Ketamine: Perioperative anesthesia medication Remifentanil: Perioperative pain medication Sufentanil: Perioperative pain medication
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients

Baseline characteristics by cohort

Measure	Intra-operative Methadone Hydrochloride n=5 Participants Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery Dexamethasone: Post operative swelling and pain control Ketamine: Perioperative anesthesia medication Remifentanil: Perioperative pain medication Sufentanil: Perioperative pain medication	Control n=5 Participants Patients administered standard of care Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery Dexamethasone: Post operative swelling and pain control Ketamine: Perioperative anesthesia medication Remifentanil: Perioperative pain medication Sufentanil: Perioperative pain medication	Total n=10 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Preoperatively

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 8 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 20 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 28 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 32 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 36 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 40 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 44 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 52 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 56 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 64 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 68 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 72 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 76 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 80 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 84 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 88 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 92 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 96 hours after surgery

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Immediately postoperatively until ambulation, on average 3-4 days

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

Unit: days. Assessments of patients' time to first ambulation post-operatively

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Immediately postoperatively until patient discharge, on average 1 week, up to 1 month

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

Unit: days. Measured at patient discharge (=length of stay)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Intraoperatively until patient discharge, on average 1 week, up to 1 month

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

Unit: mg. Amount of narcotic used intra-operatively until study completion (patient discharge)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Intraoperatively until patient discharge, on average 1 week, up to 1 month

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

Unit: number. Frequency of narcotics used intra-operatively until study completion (patient discharge)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At patient discharge, on average 1 week, up to 1 month

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

Level of rehabilitative care deemed to be required (upon patient discharge)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperatively through patient discharge, on average 1 week, up to 1 month

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

Binary assessment of need for post-operative course of Dexamethasone for post-operative/post-fusion radiculopathy or neurapraxia/neuropathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-6 months

Population: Data were not collected/aggregated and, as such, no data analysis was conducted.

Confirmation of successful fusion of lumbar vertebrae

Outcome measures

Outcome data not reported

Adverse Events

Intra-operative Methadone Hydrochloride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr. Andrew J. Kobets

Montefiore Medical Center

Phone: 718-920-7400

Email: akobets@montefiore.org

Results disclosure agreements

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