Pain, Postoperative
Conditions
Brief summary
This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores. This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.
Interventions
DEVICECold 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.
Sponsors
Cleveland Clinic Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients can understand and voluntarily sign an informed consent form 2. Female gender ages 18-65 3. Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy)
Exclusion criteria
1. Conversion to laparotomy 2. Diagnosis of chronic pelvic pain 3. No access to freezer at home to keep reusable cold packs cold between uses 4. Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum) 5. Medical contraindication to NSAID use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Score | 24 hours post-operatively following total laparoscopic hysterectomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Score | 72 hours post-operatively following total laparoscopic hysterectomy | 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. |
| Patient Reported Quantity of Narcotics Used Post-operatively | 72 hours post-operatively following total laparoscopic hysterectomy | Patient reported quantity of narcotics used post-operatively measured in number of reported 5 mg oxycodone tabs consumed |
| Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale | 72 hours post-operatively following total laparoscopic hysterectomy | Quality 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. |
| Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale | 10-14 days post-operatively following total laparoscopic hysterectomy | Functional 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Narcotics Used Post-operatively | 10-14 days postoperatively following total laparoscopic hysterectomy | Total amount of narcotics used post-operatively within the first two weeks after surgery measured in MME, intravenous morphine milligram equivalents. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Cold Therapy | Total | Control |
|---|---|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 5.8 | 46.5 years STANDARD_DEVIATION 5.9 | 47.2 years STANDARD_DEVIATION 6.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 24 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 20 Participants | 12 Participants |
| Region of Enrollment United States | 28 participants | 56 participants | 28 participants |
| Sex: Female, Male Female | 28 Participants | 56 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Post-operative Pain Score
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.
Time frame: 24 hours post-operatively following total laparoscopic hysterectomy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cold Therapy | Post-operative Pain Score | 4 units on a scale |
| Control | Post-operative Pain Score | 4.5 units on a scale |
Secondary
Patient Reported Quantity of Narcotics Used Post-operatively
Patient reported quantity of narcotics used post-operatively measured in number of reported 5 mg oxycodone tabs consumed
Time frame: 72 hours post-operatively following total laparoscopic hysterectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Therapy | Patient Reported Quantity of Narcotics Used Post-operatively | 2.52 oxycodone tabs | Standard Deviation 2.97 |
| Control | Patient Reported Quantity of Narcotics Used Post-operatively | 4.78 oxycodone tabs | Standard Deviation 6.32 |
Secondary
Post-operative Pain Score
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.
Time frame: 72 hours post-operatively following total laparoscopic hysterectomy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cold Therapy | Post-operative Pain Score | 2 score on a scale |
| Control | Post-operative Pain Score | 2.5 score on a scale |
Secondary
Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale
Quality 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.
Time frame: 72 hours post-operatively following total laparoscopic hysterectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Therapy | Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale | 43.8 score on a scale | Standard Deviation 11 |
| Control | Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale | 45.7 score on a scale | Standard Deviation 18 |
Secondary
Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale
Functional 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
Time frame: 10-14 days post-operatively following total laparoscopic hysterectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Therapy | Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale | 39.7 score on a scale | Standard Deviation 9.68 |
| Control | Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale | 38 score on a scale | Standard Deviation 10.1 |
Other Pre-specified
Total Amount of Narcotics Used Post-operatively
Total amount of narcotics used post-operatively within the first two weeks after surgery measured in MME, intravenous morphine milligram equivalents.
Time frame: 10-14 days postoperatively following total laparoscopic hysterectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Therapy | Total Amount of Narcotics Used Post-operatively | 13.3 MME, intravenous morphine milligram equi | Standard Deviation 12 |
| Control | Total Amount of Narcotics Used Post-operatively | 23.7 MME, intravenous morphine milligram equi | Standard Deviation 23.6 |