Pain, PostoperativeNCT03341533
Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy
A study testing Ice packs plus usual post-op analgesia and Usual post-op analgesia in people with Pain, Postoperative and Hysterectomy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of using ice packs on the abdomen immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain medication use. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Hysterectomy, Narcotic Use
- What is being tested?
- Ice packs plus usual post-op analgesia and Usual post-op analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 16 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing robotic or conventional laparoscopic hysterectomy
Who cannot join
- Any opioid use within 2 weeks of surgery date
- Planned post-operative ICU admission
- Conversion of laparoscopic approach to laparotomy or any incision ≥4 cm
- Regional anesthesia/analgesia, including tap block use
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial
The purpose of this study is to evaluate the effect of using ice packs on the abdomen immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain medication use.
Read the detailed description
Hysterectomy is one of the most common surgical procedures performed on women in the United States, with approximately 600,000 performed annually. The use of postoperative cooling as an adjuvant for post-operative pain control has previously been shown to be effective and safe in a variety of procedures, but has yet to be described for laparoscopic surgery. In contrast to laparotomy where the wound is a significant pain generator and direct application of ice is intuitive, in laparoscopic surgery much of the pain-generating tissue trauma is intraperitoneal and pelvic in nature, away from the abdominal wall. Ice pack use on the abdominal wall likely inhibits visceral afferent pain fibers via somatic afferent nerve cross-talk. Accordingly, applying ice to the abdominal wall and its somatic afferents may improve laparoscopic pain control, despite the lack of a significant abdominal wound. Our goal is to quantify narcotic use after hospital discharge following hysterectomy, and evaluate the effectiveness of abdominal ice packs as low cost adjuncts for pain control.
- Conditions
- Pain, Postoperative, Hysterectomy, Narcotic Use, Cryotherapy Effect
- Being tested
- Ice packs plus usual post-op analgesia, Usual post-op analgesia
- Keywords
- Analgesia, Laparoscopy, Pain
- Medical subject headings
- Pain, Postoperative, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice packs plus usual post-op analgesiaProcedure or surgery
A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.
Usual post-op analgesiaOther
Standard post-operative analgesia orders will be followed.
| Study group | Role | What they receive |
|---|---|---|
| Ice packs plus usual post-op analgesia | Experimental | Ice pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice. Receives: Procedure: Ice packs plus usual post-op analgesia; Other: Usual post-op analgesia |
| Usual post-op analgesia | Active comparator | Standard post-operative analgesia only, no ice use. Receives: Other: Usual post-op analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Intensity Scale
Self-reported pain intensity scores (Numerical Pain Intensity Scale, 0-10 visual analog scale with 0 representing no pain and 10 representing the worst pain imaginable) assessed and documented a minimum every four hours post-operatively. Mean differences of pain intensity assessed between ice group and usual care group.
Measured: 12 hours post-operatively
Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor
Calculation of average patient MME from the time enter hospital floor to hospital discharge. Administered narcotics will be abstracted from the medical record and converted to total MME for analysis.
Measured: an average of one day from entering hospital floor to discharge
Secondary outcomes (2)
Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient
Calculation of average patient MME from the time of hospital discharge to end of narcotic use for post-operative pain control. Patients will keep detailed home diary of narcotic analgesia use after discharge. Total narcotic intake recorded on the diary will be converted to MME for analysis.
Measured: 2 weeks
Brief Pain Inventory Short Form - Postoperative Pain Severity
Brief Pain Inventory Short Form scores (Pain diagram to indicate location of pain and 7 Likert-scale questions assessing pain severity and interference with feeling and function, scores ranging from 0 = No pain to 10 = pain as bad as you can imagine) assessed pre-op and again post-operatively, just before hospital discharge (at last 12 but no more than 24 hours after surgery). Mean differences calculated between ice group and usual care group.
Measured: one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start12 Jan 2018
- Primary completion5 Apr 2019
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatnai L. Burnett, Mayo Clinic
- Investigators
- Tatnai L. Burnett, M.D., Principal investigator, Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341533
- Sponsor's protocol ID
- 17-007182
- Status last verified
- May 2020
- First submitted
- 8 Nov 2017
- Last updated
- 14 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cope AG, Wetzstein MM, Mara KC, Laughlin-Tommaso SK, Warner NS, Burnett TL. Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):342-350.e2. doi: 10.1016/j.jmig.2020.06.027. Epub 2020 Jul 3.
PubMed 32622918
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03341533
- Acronym / sponsor ID
- 17-007182
- Conditions
- Pain, Postoperative, Hysterectomy, Narcotic Use, Cryotherapy Effect
- Keywords
- Analgesia, Laparoscopy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 14 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of using ice packs on the abdomen immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain medication use.
Detailed description
Hysterectomy is one of the most common surgical procedures performed on women in the United States, with approximately 600,000 performed annually. The use of postoperative cooling as an adjuvant for post-operative pain control has previously been shown to be effective and safe in a variety of procedures, but has yet to be described for laparoscopic surgery. In contrast to laparotomy where the wound is a significant pain generator and direct application of ice is intuitive, in laparoscopic surgery much of the pain-generating tissue trauma is intraperitoneal and pelvic in nature, away from the abdominal wall. Ice pack use on the abdominal wall likely inhibits visceral afferent pain fibers via somatic afferent nerve cross-talk. Accordingly, applying ice to the abdominal wall and its somatic afferents may improve laparoscopic pain control, despite the lack of a significant abdominal wound. Our goal is to quantify narcotic use after hospital discharge following hysterectomy, and evaluate the effectiveness of abdominal ice packs as low cost adjuncts for pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice packs plus usual post-op analgesia | Experimental | Procedure: Ice packs plus usual post-op analgesia, Other: Usual post-op analgesiaIce pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice. |
| Usual post-op analgesia | Active comparator | Other: Usual post-op analgesiaStandard post-operative analgesia only, no ice use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing robotic or conventional laparoscopic hysterectomy
Key exclusion criteria (4 listed)
- Any opioid use within 2 weeks of surgery date
- Planned post-operative ICU admission
- Conversion of laparoscopic approach to laparotomy or any incision ≥4 cm
- Regional anesthesia/analgesia, including tap block use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice packs plus usual post-op analgesiaA 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines. | Procedure or surgery | Ice packs plus usual post-op analgesia |
| Usual post-op analgesiaStandard post-operative analgesia orders will be followed. | Other | Ice packs plus usual post-op analgesia, Usual post-op analgesia |
Primary outcome
Numeric Pain Intensity Scale
Time frame: 12 hours post-operatively
Self-reported pain intensity scores (Numerical Pain Intensity Scale, 0-10 visual analog scale with 0 representing no pain and 10 representing the worst pain imaginable) assessed and documented a minimum every four hours post-operatively. Mean differences of pain intensity assessed between ice group and usual care group.
Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor
Time frame: an average of one day from entering hospital floor to discharge
Calculation of average patient MME from the time enter hospital floor to hospital discharge. Administered narcotics will be abstracted from the medical record and converted to total MME for analysis.
2 secondary outcomes
Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient
Time frame: 2 weeks
Brief Pain Inventory Short Form - Postoperative Pain Severity
Time frame: one day after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32622918Cope AG, Wetzstein MM, Mara KC, Laughlin-Tommaso SK, Warner NS, Burnett TL. Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):342-350.e2. doi: 10.1016/j.jmig.2020.06.027. Epub 2020 Jul 3.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatnai L. Burnett, M.D. principal investigator
Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice packs plus usual post-op analgesia and Usual post-op analgesia in people with Pain, Postoperative and Hysterectomy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Intensity Scale (time frame: 12 hours post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.