Trials / Completed
CompletedNCT02855567
Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acupuncture needles | Acupuncture needles (29 and 30 gauge) used to perform the acupuncture |
Timeline
- Start date
- 2016-08-06
- Primary completion
- 2017-12-05
- Completion
- 2017-12-05
- First posted
- 2016-08-04
- Last updated
- 2019-06-25
- Results posted
- 2019-06-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02855567. Inclusion in this directory is not an endorsement.