Trial Outcomes & Findings for Acute Pain Genomic Study (NCT NCT01557751)

Results Overview

The primary endpoint is the pain reported by subjects, using the NRS-Pain with movement on the second day after surgery.The assumption behind this study is that certain genetic variants (e.g. single-nucleotide polymorphism (SNP) are responsible for part of total variation of certain clinical phenotypes (e.g. post-operative pain here). Numeric Rating Score Pain Assessment (0-10 scale where 0 indicates no pain at all and 10 indicates the worst pain imaginable) on Post Op Day 2, Pain with Movement

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

156 participants

Primary outcome timeframe

Postoperative day (POD) 2

Results posted on

2023-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Total Knee Arthroplasty Subjects Who Are Genotyped All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc). Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.
Overall Study STARTED	156
Overall Study COMPLETED	153
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Knee Arthroplasty Subjects Who Are Genotyped All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc). Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.
Overall Study Physician Decision	3

Baseline Characteristics

Acute Pain Genomic Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Knee Arthroplasty Subjects Who Are Genotyped n=156 Participants All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc). Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants
Age, Categorical >=65 years	64 Participants n=5 Participants
Age, Continuous	64.23 years n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Region of Enrollment United States	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative day (POD) 2

The primary endpoint is the pain reported by subjects, using the NRS-Pain with movement on the second day after surgery.The assumption behind this study is that certain genetic variants (e.g. single-nucleotide polymorphism (SNP) are responsible for part of total variation of certain clinical phenotypes (e.g. post-operative pain here). Numeric Rating Score Pain Assessment (0-10 scale where 0 indicates no pain at all and 10 indicates the worst pain imaginable) on Post Op Day 2, Pain with Movement

Outcome measures

Outcome measures
Measure	Total Knee Arthroplasty Subjects Who Are Genotyped n=156 Participants All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc). Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.
NRS-Pain With Movement on POD 2	2.83 units on a scale Interval 0.0 to 10.0

Adverse Events

Total Knee Arthroplasty Subjects Who Are Genotyped

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. Jacques Chelly, MD, PHD MBA

University of Pittsburgh Medical Center (UPMC)

Phone: 412-623-6382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place