Post Operative PainNCT03711994
Cold Therapy for Pain Control Following Caesarean Section
A study testing Alkantis in people with Post Operative Pain, run by University of Tennessee at 1 site in United States.
Trial summary
Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections. The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn. Read more about this study
- Who is it for?
- Ages 16 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Alkantis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 43 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- greater than 36 weeks gestation
- primary C/S with Epidural for labor problems or breech presentation
- Repeat C/S with spinal
Who cannot join
- less than 36.0 week gestations
- vertical skin incisions
- classical or vertical hysterotomy incisions
- failed vaginal births after C/S (VBAC)
- past history of drug or alcohol abuse
- positive drug screens unless medical prescribed drugs
Show all 9Show fewer
- general anesthesia
- Caesarean Hysterectomy
- primary C/S with spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital
Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections. The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn.
Read the detailed description
Cesarean Section (C/S) is one of the most commonly performed surgeries in many parts of the world. In the United States the C/S rate in 1965 was 4.5% and increased to 30.5% in 2010. While the number of C/S has increased, pain management has primarily been via epidural, spinal, local and general anesthesia and narcotic medication for the immediate postpartum period (pp). This has lead to an increase in associated cost and problems with pain management. Limited studies have been performed to evaluate cold compresses on pain relief in the immediate pp and there potential to reduce cost. Cold Therapy (CT) is most often utilized in orthopedics, sports medicine, and in general surgery. CT has been used to improve range of motion (rom) and reduce pain medication utilization. We surmise CT may be useful in decreasing narcotic utilization after C/S, as well as improve mobility and allow for improved care of the newborn. This is significant as Erlanger Baroness Hospital (EBH) is becoming Baby Friendly (BF). This is a National Initiative for Children's Healthcare Quality (NICHQ) which desires having babies rooming in with their mothers and increasing breastfeeding rates. The goal of this study is to evaluate a newer sterile delivery system for decreasing pp pain via CT. This will be done as a Randomized Controlled Trial (RCT).
- Conditions
- Post Operative Pain
- Being tested
- Alkantis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlkantisOther
cold therapy pack placed on the wound post operatively
| Study group | Role | What they receive |
|---|---|---|
| Repeat C/S Control | No intervention | Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings. |
| Repeat C/S Treatment | Active comparator | Repeat C/S done with spinal with Alkantis ice pack. Receives: Other: Alkantis |
| Primary C/S - Control | No intervention | Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings. |
| Primary C/S Treatment | Active comparator | Primary C/S done with Epidural with Alkantis ice pack. Receives: Other: Alkantis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.
Measured: 48 hours after surgery
Secondary outcomes (1)
Narcotic Utilization
Evaluate total narcotics used during time frame
Measured: 48 hours after surgrey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study startDec 2015
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: Unable to get product at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William E Gist, M.D., Principal investigator, University of Tennessee College of Medicine- ChattanoogaKreg Jonson, M.D., Study director, University of Tennessee College of Medicine- ChattanoogaMandi Raper, Study director, University of Tennessee College of Medicine- ChattanoogaErin Tannous, MD, Study director, University of Tennessee College of Medicine- ChattanoogaOlkayoude Akinlaja, MD, Study chair, University of Tennessee College of Medicine- Chattanooga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711994
- Sponsor's protocol ID
- 14-133
- Status last verified
- Apr 2018
- First submitted
- 25 Jan 2016
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Placek PJ, Taffel SM. Trends in cesarean section rates for the United States, 1970--78. Public Health Rep. 1980 Nov-Dec;95(6):540-8.
PubMed 7433601Placek PJ, Taffel S, Moien M. Cesarean section delivery rates: United States, 1981. Am J Public Health. 1983 Aug;73(8):861-2. doi: 10.2105/ajph.73.8.861.
PubMed 6869638Stafford RS. Alternative strategies for controlling rising cesarean section rates. JAMA. 1990 Feb 2;263(5):683-7.
PubMed 2296123Amin-Hanjani S, Corcoran J, Chatwani A. Cold therapy in the management of postoperative cesarean section pain. Am J Obstet Gynecol. 1992 Jul;167(1):108-9. doi: 10.1016/s0002-9378(11)91638-x.
PubMed 1442907Koc M, Tez M, Yoldas O, Dizen H, Gocmen E. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia. 2006 Apr;10(2):184-6. doi: 10.1007/s10029-005-0062-2. Epub 2006 Jan 24.
PubMed 16432641Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. doi: 10.1016/j.arth.2006.02.159.
PubMed 17162178Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital
- ClinicalTrials.gov ID
- NCT03711994
- Acronym / sponsor ID
- 14-133
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to get product at this time
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections. The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn.
Detailed description
Cesarean Section (C/S) is one of the most commonly performed surgeries in many parts of the world. In the United States the C/S rate in 1965 was 4.5% and increased to 30.5% in 2010. While the number of C/S has increased, pain management has primarily been via epidural, spinal, local and general anesthesia and narcotic medication for the immediate postpartum period (pp). This has lead to an increase in associated cost and problems with pain management. Limited studies have been performed to evaluate cold compresses on pain relief in the immediate pp and there potential to reduce cost. Cold Therapy (CT) is most often utilized in orthopedics, sports medicine, and in general surgery. CT has been used to improve range of motion (rom) and reduce pain medication utilization. We surmise CT may be useful in decreasing narcotic utilization after C/S, as well as improve mobility and allow for improved care of the newborn. This is significant as Erlanger Baroness Hospital (EBH) is becoming Baby Friendly (BF). This is a National Initiative for Children's Healthcare Quality (NICHQ) which desires having babies rooming in with their mothers and increasing breastfeeding rates. The goal of this study is to evaluate a newer sterile delivery system for decreasing pp pain via CT. This will be done as a Randomized Controlled Trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Repeat C/S Control | No intervention | –Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings. |
| Repeat C/S Treatment | Active comparator | Other: AlkantisRepeat C/S done with spinal with Alkantis ice pack. |
| Primary C/S - Control | No intervention | –Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings. |
| Primary C/S Treatment | Active comparator | Other: AlkantisPrimary C/S done with Epidural with Alkantis ice pack. |
Who may qualify
- Ages
- 16 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- greater than 36 weeks gestation
- primary C/S with Epidural for labor problems or breech presentation
- Repeat C/S with spinal
Key exclusion criteria (9 listed)
- less than 36.0 week gestations
- vertical skin incisions
- classical or vertical hysterotomy incisions
- failed vaginal births after C/S (VBAC)
- past history of drug or alcohol abuse
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 |
|---|---|---|
| Alkantiscold therapy pack placed on the wound post operatively | Other | Primary C/S Treatment, Repeat C/S Treatment |
Primary outcome
Post Operative Pain
Time frame: 48 hours after surgery
Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.
1 secondary outcome
Narcotic Utilization
Time frame: 48 hours after surgrey
Results and safety
The study was stopped early (reason given: Unable to get product at this time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Background: PubMed 7433601Placek PJ, Taffel SM. Trends in cesarean section rates for the United States, 1970--78. Public Health Rep. 1980 Nov-Dec;95(6):540-8.
- Background: PubMed 6869638Placek PJ, Taffel S, Moien M. Cesarean section delivery rates: United States, 1981. Am J Public Health. 1983 Aug;73(8):861-2. doi: 10.2105/ajph.73.8.861.
- Background: PubMed 2296123Stafford RS. Alternative strategies for controlling rising cesarean section rates. JAMA. 1990 Feb 2;263(5):683-7.
- Background: PubMed 1442907Amin-Hanjani S, Corcoran J, Chatwani A. Cold therapy in the management of postoperative cesarean section pain. Am J Obstet Gynecol. 1992 Jul;167(1):108-9. doi: 10.1016/s0002-9378(11)91638-x.
- Background: PubMed 16432641Koc M, Tez M, Yoldas O, Dizen H, Gocmen E. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia. 2006 Apr;10(2):184-6. doi: 10.1007/s10029-005-0062-2. Epub 2006 Jan 24.
- Background: PubMed 17162178Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. doi: 10.1016/j.arth.2006.02.159.
- Derived from this study: PubMed 32871021Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
- 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.
William E Gist, M.D. principal investigator
University of Tennessee College of Medicine- Chattanooga
Kreg Jonson, M.D. study director
University of Tennessee College of Medicine- Chattanooga
Mandi Raper study director
University of Tennessee College of Medicine- Chattanooga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alkantis in people with Post Operative Pain, run by University of Tennessee 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Jun 2022. 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?
The study was stopped early (reason given: Unable to get product at this time). Results are not available in the source record.
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?
Post Operative Pain (time frame: 48 hours after surgery). 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 NCT03711994, which also lists 7 linked publications.
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 2 Jun 2022.