Ice Application for Postoperative Pain

Postoperative Pain Clinical Trial

— Ice-POP  

Official title:

Ice Application for Postoperative Pain: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145791
• Other study ID #: 072018-055
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: February 3, 2021

Study information

• Verified date: February 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Ice
ice packs

Locations

Country	Name	City	State
United States	Clements University Hospital	Dallas	Texas
United States	Parkland Health and Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score of cryotherapy patients as compared to non-cryotherapy patients	To determine if cryotherapy patients will have lower pain scores on a visual analog scale (VAS) compared to standard pain management patients at the time of same day discharge. VAS requires that patients mark their level pain along a straight 100mm line. There are no number markings on the scale. The beginning of the line is labeled on the left as "no pain" and the end of the line on the right is labeled as "worst pain imaginable." Once marked by the patient, the distance from beginning of the line to the patient's hash mark is measured in millimeters and that value is recorded as the pain level. The minimum is 0 (no pain) and the maximum is 100 (worst pain imaginable).	pain score collected at admission to the preoperative holding unit prior to surgery
Primary	Pain score of cryotherapy patients as compared to non-cryotherapy patients	To determine if cryotherapy patients will have lower pain scores on a visual analog scale (VAS) compared to standard pain management patients at the time of same day discharge. VAS requires that patients mark their level pain along a straight 100mm line. There are no number markings on the scale. The beginning of the line is labeled on the left as "no pain" and the end of the line on the right is labeled as "worst pain imaginable." Once marked by the patient, the distance from beginning of the line to the patient's hash mark is measured in millimeters and that value is recorded as the pain level. The minimum is 0 (no pain) and the maximum is 100 (worst pain imaginable).	pain score collected immediately after surgery
Primary	Pain score of cryotherapy patients as compared to non-cryotherapy patients	To determine if cryotherapy patients will have lower pain scores on a visual analog scale (VAS) compared to standard pain management patients at the time of same day discharge. VAS requires that patients mark their level pain along a straight 100mm line. There are no number markings on the scale. The beginning of the line is labeled on the left as "no pain" and the end of the line on the right is labeled as "worst pain imaginable." Once marked by the patient, the distance from beginning of the line to the patient's hash mark is measured in millimeters and that value is recorded as the pain level. The minimum is 0 (no pain) and the maximum is 100 (worst pain imaginable).	pain score collected post operative day 1
Primary	Pain score of cryotherapy patients as compared to non-cryotherapy patients	To determine if cryotherapy patients will have lower pain scores on a visual analog scale (VAS) compared to standard pain management patients at the time of same day discharge. VAS requires that patients mark their level pain along a straight 100mm line. There are no number markings on the scale. The beginning of the line is labeled on the left as "no pain" and the end of the line on the right is labeled as "worst pain imaginable." Once marked by the patient, the distance from beginning of the line to the patient's hash mark is measured in millimeters and that value is recorded as the pain level. The minimum is 0 (no pain) and the maximum is 100 (worst pain imaginable).	pain score collected at two weeks post operative.
Secondary	Narcotic usage	Amount of narcotic pain medicines used as measured in morphine milligram equivalent (MME).	postoperative day one
Secondary	Quality of Recovery (QoR)	Return to baseline activity as measured by QoR questionnaire. The questionnaire consists of 15 items, 10 in Part A and 5 in Part B. Part A assesses patients daily functioning and utilizes a Likert scale 0 to 10, where 0 = none of the time [poor] and 10 = all of the time [excellent]. Park B asses symptomatology and utilizes a Likert scale (0 to 10, where 10 = none of the time [excellent] and 0 = all of the time [poor].	through study completion to take place at preoperative visit, and post operative day #14.
Secondary	Time to discharge	Duration of time in minutes between admission to postanesthesia care unit (PACU) and discharge home as recorded in the electronic health record.	day of surgery, up to 1440 minutes