Comparing two pain management techniques after major breast cancer surgery
Quality of Recovery After Major Breast Cancer Surgery: a Prospective Multicentre Randomized Triple Blinded Trial Comparing Erector Spinae Plane Block and Intravenous Lidocaine Infusion
This study is testing whether a new pain management technique using a nerve block works better than an intravenous pain medication for people recovering from major breast cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06490718 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the quality of recovery between the erector spinae plane block (ESPB) and intravenous lidocaine infusion (IVLI) in patients undergoing major breast cancer surgery. The study will involve a multicenter, randomized, triple-blind design to assess postoperative pain management and recovery outcomes. ESPB is a regional anesthetic technique that is gaining popularity due to its safety and simplicity, while IVLI offers a non-invasive alternative that may provide similar analgesic benefits. The trial will include patients scheduled for mastectomy or modified radical mastectomy and will evaluate the effectiveness of these two approaches in reducing acute and chronic postoperative pain.
Who should consider this trial
Good fit: Ideal candidates for this study are ASA I-III patients aged 18 to 75 scheduled for primary breast cancer surgery.
Not a fit: Patients who may not benefit from this study include those with local skin site infections, coagulopathy, or a history of allergy to local anesthetics.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing major breast cancer surgery.
How similar studies have performed: While there is emerging evidence supporting the use of ESPB and IVLI in various surgical settings, specific data on their comparative effectiveness in major breast cancer surgery remains limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-III patients * 18 to 75 years of age * Patients scheduled for primary breast cancer surgery-mastectomy, modified radical mastectomy and breast conservation surgery with sentinel lymph node biopsy +/- axillary dissection will be included in this study. Exclusion Criteria: * Patient refusal, * Local skin site infection, * Coagulopathy, * History of allergy to local anaesthetics, and * Patients with hepatic, renal and cardiac dysfunction
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- The First Affiliated Hospital — Guangzhou, Guangdong, China (Recruiting)
- North District Hospital — Sheung Shui, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Manoj K Karmakar, MD, FRCA — Chinese University of Hong Kong
- Study coordinator: Ayla Wong, RN, BN
- Email: aylawong@cuhk.edu.hk
- Phone: 35056157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.