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Completed

NCT Number: NCT04145791

Ice Application for Postoperative Pain

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clements University Hospital, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ice

Other

ice packs

Primary outcomes

  1. Pain score of cryotherapy patients as compared to non-cryotherapy patients

    Time frame: pain score collected at admission to the preoperative holding unit prior to surgery

    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).

  2. Pain score of cryotherapy patients as compared to non-cryotherapy patients

    Time frame: pain score collected immediately after surgery

    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).

  3. Pain score of cryotherapy patients as compared to non-cryotherapy patients

    Time frame: pain score collected post operative day 1

    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).

  4. Pain score of cryotherapy patients as compared to non-cryotherapy patients

    Time frame: pain score collected at two weeks post operative.

    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).

Secondary outcomes

  1. Narcotic usage

    Time frame: postoperative day one

    Amount of narcotic pain medicines used as measured in morphine milligram equivalent (MME).

  2. Quality of Recovery (QoR)

    Time frame: through study completion to take place at preoperative visit, and post operative day #14.

    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].

  3. Time to discharge

    Time frame: day of surgery, up to 1440 minutes

    Duration of time in minutes between admission to postanesthesia care unit (PACU) and discharge home as recorded in the electronic health record.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Ice Application for Postoperative Pain: a Randomized Control Trial

Acronym: Ice-POP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2019
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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