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| ID | Type | Description | Link |
|---|---|---|---|
| mazuike | Other Identifier | Xijing Hospital |
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| Name | Class |
|---|---|
| Northwest Women's and Children's Hospital, Xi'an, Shaanxi | OTHER |
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To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative gastrointestinal complications after cesarean section under combined spinal epidural anesthesia compared with control and non-acupoint group.
Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases.Clinical evidence supports the efficacy of acupuncture treatment in many applications. Some previous studies reported that stimulation at some acupoint exerted good effects on the digestive system.Compared with acupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique that has similar effects to acupuncture.We hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after Cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAS group | Experimental | TEAS are performed by a specific investigator on the specially acupoint. |
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| Sham group | Sham Comparator | TEAS are performed by a specific investigator on the non-acupoint. |
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| Control group | Placebo Comparator | Only place cutted electrodes but do not give any electrical stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEAS | Device | According to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves. Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the presence of bowel sound, time to the first passage of flatus, time to the first passage of stool , time to the start of regular diet | This is a composite outcome to estimate the gastrointestinal motility function | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Electrogastrogram | The first and second days after surgery | |
| Rate of nausea, vomiting, cramping abdominal pain, abdominal distension | This is a composite outcome to estimate the complication of digestive system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiang Wang | Xijing Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20195124 | Background | Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23. | |
| 11506105 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 8, 2017 | |
| Reset | Sep 7, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 8, 2017 | Sep 7, 2017 |
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| Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| length of postoperative hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Quality of life during 30 days after surgery | This is a scale to evaluate the quality of life after surgery | One month |
| Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015. |
| 25146082 | Background | Cheong KB, Zhang JP, Huang Y. The effectiveness of acupuncture in postoperative gastroparesis syndrome--a systematic review and meta-analysis. Complement Ther Med. 2014 Aug;22(4):767-86. doi: 10.1016/j.ctim.2014.05.002. Epub 2014 May 12. |
| 19234827 | Background | Oshima M, Aoyama K, Warabi K, Akazawa T, Inada E. Electrogastrography during and after cesarean delivery. J Anesth. 2009;23(1):75-9. doi: 10.1007/s00540-008-0692-5. Epub 2009 Feb 22. |
| 22309587 | Background | Dresang LT, Leeman L. Cesarean delivery. Prim Care. 2012 Mar;39(1):145-65. doi: 10.1016/j.pop.2011.11.007. |