Post-operative PainNCT02855567
Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
A study testing Acupuncture needles in people with Post-operative Pain and Gynecological Surgery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Gynecological Surgery, Acupuncture
- What is being tested?
- Acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2016to 5 Dec 2017
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female patients
- over the age of 18
- scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa
Who cannot join
- male patients
- pregnancy
- suspected or known malignant disease
- immunocompromised
- known or persistent abuse of medications, drugs or alcohol
- chronic pain for greater than 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.
Read the detailed description
The goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time. To do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication. These patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia. The acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting. The needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery. The sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture. For both groups, the acupuncture needles will be removed before the first incision of the surgery. All patients will be blinded to their group allocation.
- Conditions
- Post-operative Pain, Gynecological Surgery, Acupuncture
- Being tested
- Acupuncture needles
- Keywords
- surgery, acupuncture, gynecology, pain, narcotics
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Receives acupuncture during gynecological surgery at 5 known points for pain control. Needles will be placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient is prepped for surgery. They will be in place for 15 minutes. Receives: Device: Acupuncture needles |
| Sham acupuncture | Sham comparator | Receives acupuncture during gynecological surgery at sham points not associated with pain control. Needles will be placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles will be removed immediately after placement. Receives: Device: Acupuncture needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalent Usage While in the Hospital
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.
Measured: Intra-operative and 24 hours post-operatively
Secondary outcomes (4)
Number of Pain Medication Tablets Used at Home Post-Operatively
Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.
Measured: 7 days post-operatively
Number of Patients Readmitted to the Hospital
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.
Measured: 2 weeks post-operatively
Pain Score
Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain
Measured: up to 4 hours post operatively
Pain Score at Home Post-Operatively
Pain Score from 0-10 with higher score indicating more pain
Measured: up to 7 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start6 Aug 2016
- Primary completion5 Dec 2017
- Study completion5 Dec 2017
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.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Ascher-Walsh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855567
- Sponsor's protocol ID
- GCO 16-1120
- Status last verified
- Jun 2019
- First submitted
- 29 Jul 2016
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
- ClinicalTrials.gov ID
- NCT02855567
- Acronym / sponsor ID
- GCO 16-1120
- Conditions
- Post-operative Pain, Gynecological Surgery, Acupuncture
- Keywords
- surgery, acupuncture, gynecology, pain, narcotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 6 Aug 2016 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.
Detailed description
The goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time. To do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication. These patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia. The acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting. The needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery. The sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture. For both groups, the acupuncture needles will be removed before the first incision of the surgery. All patients will be blinded to their group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Device: Acupuncture needlesReceives acupuncture during gynecological surgery at 5 known points for pain control. Needles will be placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient is prepped for surgery. They will be in place for 15 minutes. |
| Sham acupuncture | Sham comparator | Device: Acupuncture needlesReceives acupuncture during gynecological surgery at sham points not associated with pain control. Needles will be placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles will be removed immediately after placement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients
- over the age of 18
- scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa
Key exclusion criteria (6 listed)
- male patients
- pregnancy
- suspected or known malignant disease
- immunocompromised
- known or persistent abuse of medications, drugs or alcohol
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 |
|---|---|---|
| Acupuncture needlesAcupuncture needles (29 and 30 gauge) used to perform the acupuncture | Device | Acupuncture, Sham acupuncture |
Primary outcome
Morphine Equivalent Usage While in the Hospital
Time frame: Intra-operative and 24 hours post-operatively
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.
4 secondary outcomes
Number of Pain Medication Tablets Used at Home Post-Operatively
Time frame: 7 days post-operatively
Number of Patients Readmitted to the Hospital
Time frame: 2 weeks post-operatively
Pain Score
Time frame: up to 4 hours post operatively
Pain Score at Home Post-Operatively
Time frame: up to 7 days post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Charles Ascher-Walsh, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture needles in people with Post-operative Pain and Gynecological Surgery, run by Icahn School of Medicine at Mount Sinai 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 6 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 25 Jun 2019. 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. Some participants in this study may receive a placebo. 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 19 Jun 2019). 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?
Morphine Equivalent Usage While in the Hospital (time frame: Intra-operative and 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2019.