Ice Application for Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2021-02-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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No Ice

Patients will receive standard postoperative pain control methods as defined by the participating institution

Group Type NO_INTERVENTION

No interventions assigned to this group

Ice

Patients will receive ice packs to the abdomen, in addition to standard postoperative pain control methods as defined by the participating institution

Group Type EXPERIMENTAL

Ice

Intervention Type OTHER

ice packs

Interventions

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Ice

ice packs

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes