Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After Hysterectomy (RAACU)
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ClinicalTrials.gov Identifier: NCT06002464 |
Recruitment Status :
Recruiting
First Posted : August 21, 2023
Last Update Posted : September 8, 2023
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Since the 90's, the quality of the post operative pain relief is a main concern in most of the healthcare systems in the world. An efficient pain relief improves the quality of recovery after surgery [Level 1A], reduces the risk of persistent pain [level 1A] and makes the patients satisfied.
Continuous regional anesthesia/analgesia promotes a level 1A in quality of postoperative pain relief, reduction in opioids consumption in opioid sparing/free analgesia programs, time to recover and the reduction of hospital stay. However in the postoperative period, breakthrough pain episodes due to mobilization or activity are not well covered by regional analgesia. Furthermore, after removal of the catheter of regional anesthesia, patients may face an unpleasant rebound pain effect.
At VinMec, the technique of regional anesthesia chosen to provide regional analgesia after hysterectomy is a bilateral erector spinae plane block .
Traditional Medicine relieves pain by non-pharmacological methods, especially by acupuncture which bring positive results. Acupuncture has been proven to provide pain relief according to the mechanism of traditional and modern medicine, safe for patients and with few side effects. The acupunture point formula is used by VinMec Sao Phuong Dong Traditional Medicine Center in conjunction with the department of Anesthesiology and Pain management in VinMec Times City International General Hospital to relieve pain after hysterectomy including: Three Yin Intersection (SP-6), Leg Three Miles (ST-36), Taichong (LR-3), Xuehai (SP-10).
The study is to observe the effect of combining acupuncture with regional anesthesia on pain relief and postoperative recovery in patients undergoing hysterectomy.
There is no published study regarding the effects of combining the 2 techniques above as multimodal approach for post operative analgesia after hysterectomy.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Postoperative | Procedure: Acupuncture Procedure: Bilateral ESP catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A single center, open label, prospective randomized controlled trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After Hysterectomy |
Actual Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | October 1, 2024 |
Estimated Study Completion Date : | November 1, 2024 |
Arm | Intervention/treatment |
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Active Comparator: ESP
Post operative analgesia with bilateral continuous erector spinae plane block catheter
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Procedure: Bilateral ESP catheter
Analgesia by Bilateral Continuous erector spine plane block catheter at T9 level for 2 days |
Experimental: ESP ACU
Post operative analgesia with bilateral continuous erector spinae plane block catheter combined with daily session of acupuncture
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Procedure: Acupuncture
Patient will have session of 30 minutes of acupuncture every day during 3 days Procedure: Bilateral ESP catheter Analgesia by Bilateral Continuous erector spine plane block catheter at T9 level for 2 days |
- quality of pain relief [ Time Frame: from end of surgery to 3rd day after the surgery ]the area under the curves the Visual analgesia Scores for pain at rest and pain at mobilization
- Opioid consumption [ Time Frame: from end of surgery to 3rd day after the surgery ]the total morphine consumption used to reach the desired level of pain control
- Quality of recovery [ Time Frame: measured on 4th day after surgery ]By using a published score of quality of recovery after anesthesia for surgery, the QOR 15
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Patients listed for hysterectomy |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- female
- elective hysterectomy
- accept ton participate
- signed consent
Exclusion Criteria:
- patient refusal
- allergy to local anesthetics
- complex congenital malformation
- mental deficit
- substance abuse(alcohol, drugs, opioids)
- renal insufficiency
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002464
Contact: Huyen Vu | (024)39750028 ext 6280 | v.huyenvx@vinmec.com |
Vietnam | |
Vinmec international hospital | Recruiting |
Hanoi, Vietnam, 10000 | |
Contact: Philippe Macaire ph.macaire@gmail.com |
Principal Investigator: | Philippe Macaire, MD | Vinmec Healthcare System |
Responsible Party: | Vinmec Healthcare System |
ClinicalTrials.gov Identifier: | NCT06002464 |
Other Study ID Numbers: |
VMEC ANEST 16 |
First Posted: | August 21, 2023 Key Record Dates |
Last Update Posted: | September 8, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |