Clinical trial NCT04145791: Ice Application for Postoperative Pain
Official title: Ice Application for Postoperative Pain: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial.

Detailed description: The purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial. The following aims will be pursued:

Primary Aim: To determine if cryotherapy patients will have lower pain scores on VAS compared to standard pain management patients.

Primary Hypothesis: Patients receiving cryotherapy will have lower VAS scores compared to patients receiving pain management.

Secondary Aim 1: To determine if cryotherapy will reduce the number of morphine milligram equivalent (MME) compared to patients with standard pain management.

Secondary Hypothesis 1: Patients receiving cryotherapy will have lower MME values compared to patients with standard pain management.

Secondary Aim 2: To determine if cryotherapy will result in earlier return to baseline activity as measured by Quality of Recovery Questionnaire (QoR).

Secondary Hypothesis 2: Patients receiving cryotherapy will return to baseline activity level sooner than those receiving standard pain management.

Secondary Aim 3: To determine if cryotherapy will result in a faster time to discharge as determined by duration between admission to postanesthesia care unit (PACU) and discharge home.

Secondary Hypothesis 3: Patient receiving cryotherapy will be have a shorter stay in PACU.

Eligibility criteria: Inclusion Criteria:

* Women undergoing laparoscopic hysterectomy for benign indications within 8 weeks of enrollment
* Women \>18 years of age
* Non-emergent surgery
* Non-pregnant
* Women undergoing laparoscopic hysterectomy with the minimally invasive surgery team

Exclusion Criteria:

* Requires surgery for urinary incontinence
* Has acute angle glaucoma
* Has severe cardiac/respiratory disease
* Current chronic pain condition (ie chronic pelvic pain, fibromyalgia, chronic low back pain)
* Chronic use/abuse of opioid medications for greater than 1 week preceding procedure
* Chronic NSAID use
* Current treatment of opioid dependence with methadone or buprenorphine
* Non-English or Non-Spanish speaking
* Procedure converted to laparotomy

Primary outcomes:
measure: Pain score of cryotherapy patients as compared to non-cryotherapy patients
timeFrame: pain score collected at admission to the preoperative holding unit prior to surgery
measure: Pain score of cryotherapy patients as compared to non-cryotherapy patients
timeFrame: pain score collected immediately after surgery
measure: Pain score of cryotherapy patients as compared to non-cryotherapy patients
timeFrame: pain score collected post operative day 1
measure: Pain score of cryotherapy patients as compared to non-cryotherapy patients
timeFrame: pain score collected at two weeks post operative.
Secondary outcomes:
measure: Narcotic usage
timeFrame: postoperative day one
measure: Quality of Recovery (QoR)
timeFrame: through study completion to take place at preoperative visit, and post operative day #14.
measure: Time to discharge
timeFrame: day of surgery, up to 1440 minutes
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: Clements University Hospital
state: Texas
Study officials:
affiliation: University of Texas as Southwestern Medical Center
name: Kimberly Kho, MD
role: PRINCIPAL_INVESTIGATOR
References: