Trial Outcomes & Findings for Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores (NCT NCT02408263)

Results Overview

Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain)

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Baseline, Postoperative day 1, Postoperative Day 2

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Total Hip Replacement (THR) Patients undergoing unilateral hip replacement (THR) that are between the ages of 18 and 85. Patients with the condition of chronic pain, using long acting opioid medication \>6 months will be excluded.	Total Knee Replacement (TKR) Patients undergoing unilateral knee replacement (TKR) that are between the ages of 18 and 85. Patients with the condition of chronic pain, using long acting opioid medication \>6 months will be excluded.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	THR and TKR n=50 Participants
Age, Continuous	64.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Postoperative day 1, Postoperative Day 2

Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	THR and TKR n=50 Participants
Numeric Pain Rating Scale Baseline	2.0 units on a scale Standard Deviation 2.2
Numeric Pain Rating Scale Postoperative day 1	2.7 units on a scale Standard Deviation 2.4
Numeric Pain Rating Scale Postoperative day 2	2.9 units on a scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: Baseline, Postoperative day 1, Postoperative day 2

A skin conductance response is defined as a minimum followed by a maximum in conductance values micro Siemens (mS).

Outcome measures

Outcome measures
Measure	THR and TKR n=50 Participants
Skin Conductance Response Baseline	0.13 micro Siemens (mS) Standard Deviation 0.15
Skin Conductance Response Postoperative day 1	0.08 micro Siemens (mS) Standard Deviation 0.12
Skin Conductance Response Postoperative day 2	0.11 micro Siemens (mS) Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline, Postoperative day 1, Postoperative day 2

Nausea was assessed by patients' self-report on their level of nausea on a 0-3 scale: 0=No nausea; 1=Mild nausea; 2=Moderate nausea; 3=Severe nausea.

Outcome measures

Outcome measures
Measure	THR and TKR n=50 Participants
Nausea Baseline	0.16 units on a scale Standard Deviation 0.51
Nausea Postoperative day 1	0.20 units on a scale Standard Deviation 0.60
Nausea Postoperative day 2	0.16 units on a scale Standard Deviation 0.51

Adverse Events

THR and TKR

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. Gungor

HSS

Phone: 212.606.1206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place