Ice Application for Postoperative Pain (Ice-POP)

The University of Texas System (UT)

Status: Completed

Conditions: Postoperative Pain

Treatments: Other: Ice

Study type: Interventional

Funder types: Other

Identifiers

NCT04145791

072018-055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

No Ice

No Intervention group

Description:

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

Ice

Experimental group

Description:

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

Treatment:

Other: Ice