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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
56
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.
Cleveland Clinic Florida
Weston, Florida, United States
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
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
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
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
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
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