Trial Outcomes & Findings for Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management (NCT NCT03129464)
NCT ID: NCT03129464
Last Updated: 2024-10-18
Results Overview
Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
24 hours post-operatively following total laparoscopic hysterectomy
Results posted on
2024-10-18
Participant Flow
Participant milestones
| Measure |
Cold Therapy
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management
Baseline characteristics by cohort
| Measure |
Cold Therapy
n=28 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
n=28 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 6.19 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-operatively following total laparoscopic hysterectomyPost-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.
Outcome measures
| Measure |
Cold Therapy
n=28 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
n=27 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
|---|---|---|
|
Post-operative Pain Score
|
4 units on a scale
Interval 2.0 to 6.0
|
4.5 units on a scale
Interval 3.0 to 5.75
|
SECONDARY outcome
Timeframe: 72 hours post-operatively following total laparoscopic hysterectomyPost-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.
Outcome measures
| Measure |
Cold Therapy
n=25 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
n=27 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
|---|---|---|
|
Post-operative Pain Score
|
2 score on a scale
Interval 1.0 to 4.0
|
2.5 score on a scale
Interval 1.25 to 5.75
|
SECONDARY outcome
Timeframe: 72 hours post-operatively following total laparoscopic hysterectomyPatient reported quantity of narcotics used post-operatively measured in number of reported 5 mg oxycodone tabs consumed
Outcome measures
| Measure |
Cold Therapy
n=25 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
n=27 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
|---|---|---|
|
Patient Reported Quantity of Narcotics Used Post-operatively
|
2.52 oxycodone tabs
Standard Deviation 2.97
|
4.78 oxycodone tabs
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: 72 hours post-operatively following total laparoscopic hysterectomyQuality of life score as measured by the validated Abdominal Surgery Impact Scale, minimum value is 18, maximum value is 126, with lower values indicating a worse quality of life and higher scores indicating a better quality of life.
Outcome measures
| Measure |
Cold Therapy
n=25 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
n=27 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
|---|---|---|
|
Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale
|
43.8 score on a scale
Standard Deviation 11
|
45.7 score on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 10-14 days post-operatively following total laparoscopic hysterectomyFunctional surgical recovery following major surgery as measured by the validated Surgical Recovery Scale, possible scores range from 0 to 60, with higher scores indicating a better recovery
Outcome measures
| Measure |
Cold Therapy
n=28 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
n=28 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
|---|---|---|
|
Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale
|
39.7 score on a scale
Standard Deviation 9.68
|
38 score on a scale
Standard Deviation 10.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-14 days postoperatively following total laparoscopic hysterectomyTotal amount of narcotics used post-operatively within the first two weeks after surgery measured in MME, intravenous morphine milligram equivalents.
Outcome measures
| Measure |
Cold Therapy
n=28 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
|
Control
n=28 Participants
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
|
|---|---|---|
|
Total Amount of Narcotics Used Post-operatively
|
13.3 MME, intravenous morphine milligram equi
Standard Deviation 12
|
23.7 MME, intravenous morphine milligram equi
Standard Deviation 23.6
|
Adverse Events
Cold Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place