Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After Hysterectomy

NCT06002464 | Unknown DMC

• 1 other identifier: VMEC ANEST 16
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• quality of pain relief

  the area under the curves the Visual analgesia Scores for pain at rest and pain at mobilization

  from end of surgery to 3rd day after the surgery

Secondary Outcomes (2)

• Opioid consumption

  from end of surgery to 3rd day after the surgery

• Quality of recovery

  measured on 4th day after surgery

Study Arms (2)

ESP

ACTIVE COMPARATOR

Post operative analgesia with bilateral continuous erector spinae plane block catheter

Procedure: Bilateral ESP catheter

ESP ACU

EXPERIMENTAL

Post operative analgesia with bilateral continuous erector spinae plane block catheter combined with daily session of acupuncture

Procedure: Acupuncture; Procedure: Bilateral ESP catheter

Interventions

Acupuncture PROCEDURE

Patient will have session of 30 minutes of acupuncture every day during 3 days

ESP ACU

Bilateral ESP catheter PROCEDURE

Analgesia by Bilateral Continuous erector spine plane block catheter at T9 level for 2 days

ESP; ESP ACU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Patients listed for hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• elective hysterectomy
• accept ton participate
• signed consent

You may not qualify if:

• patient refusal
• allergy to local anesthetics
• complex congenital malformation
• mental deficit
• substance abuse(alcohol, drugs, opioids)
• renal insufficiency

Sponsors & Collaborators

• Vinmec Healthcare System: lead

Study Sites (1)

Vinmec international hospital

Hanoi, 10000, Vietnam

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Philippe Macaire, MD

  Vinmec Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huyen Vu

CONTACT

(024)39750028; v.huyenvx@vinmec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single center, open label, prospective randomized controlled trial

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)