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Completed

NCT Number: NCT03129464

Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management

This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores.

This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients can understand and voluntarily sign an informed consent form
  • Female gender ages 18-65
  • Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy)

Exclusion criteria

  • Conversion to laparotomy
  • Diagnosis of chronic pelvic pain
  • No access to freezer at home to keep reusable cold packs cold between uses
  • Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum)
  • Medical contraindication to NSAID use

Treatment and study plan

Cold therapy via reusable cold gel pack

Device

Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.

Primary outcomes

  1. Post-operative Pain Score

    Time frame: 24 hours post-operatively following total laparoscopic hysterectomy

    Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.

Secondary outcomes

  1. Post-operative Pain Score

    Time frame: 72 hours post-operatively following total laparoscopic hysterectomy

    Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.

  2. Patient Reported Quantity of Narcotics Used Post-operatively

    Time frame: 72 hours post-operatively following total laparoscopic hysterectomy

    Patient reported quantity of narcotics used post-operatively measured in number of reported 5 mg oxycodone tabs consumed

  3. Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale

    Time frame: 72 hours post-operatively following total laparoscopic hysterectomy

    Quality of life score as measured by the validated Abdominal Surgery Impact Scale, minimum value is 18, maximum value is 126, with lower values indicating a worse quality of life and higher scores indicating a better quality of life.

  4. Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale

    Time frame: 10-14 days post-operatively following total laparoscopic hysterectomy

    Functional surgical recovery following major surgery as measured by the validated Surgical Recovery Scale, possible scores range from 0 to 60, with higher scores indicating a better recovery

Other outcomes

  1. Total Amount of Narcotics Used Post-operatively

    Time frame: 10-14 days postoperatively following total laparoscopic hysterectomy

    Total amount of narcotics used post-operatively within the first two weeks after surgery measured in MME, intravenous morphine milligram equivalents.

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Florida

Other

Registry information

Official study title

Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2017
Registry last updated
Oct 18, 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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