Using Rhomboid Intercostal Block to Reduce Pain After Mastectomy
The Effect of Single Shot Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy Surgery
This study is testing if a special pain relief technique called the Rhomboid Intercostal Block can help women feel less pain after having a mastectomy for breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Muğla Sıtkı Koçman University Academic / other |
| Locations | 1 site (Mugla, Menteşe) |
| Trial ID | NCT06019325 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Rhomboid Intercostal Block (RIB) in reducing both acute and chronic pain in women undergoing mastectomy for breast cancer. It is a prospective, double-blinded, randomized controlled trial where participants will either receive the RIB or no block intervention following surgery. Pain levels will be assessed at various postoperative intervals using a Numerical Rating Scale, and the incidence of chronic pain will be compared between the two groups at three and six months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18-65 who are undergoing breast cancer surgery under general anesthesia.
Not a fit: Patients with a history of chronic opioid use, certain psychiatric conditions, or those with infections at injection sites may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of chronic pain in breast cancer surgery patients.
How similar studies have performed: Previous studies have shown that similar nerve blocks can effectively manage acute postoperative pain, but the impact on chronic pain remains less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-II patients * Female * Ages between 18-65 * Patients who will receive breast cancer surgery under general anesthesia Exclusion Criteria: * Alcohol or substance or chronic opioid consumption story * Any pain killers intake in the last 24 hours prior to surgery * Body mass index over 35 kg/m2 * Infection at the injection sites * Known allergy to local anesthetics * Known psychiatric diseases which prevents communication * Operations longer than 3 hours
Where this trial is running
Mugla, Menteşe
- Muğla Training and Research Hospital — Mugla, Menteşe, Turkey (Recruiting)
Study contacts
- Study coordinator: BAŞAK ALTIPARMAK, Ass Prof
- Email: basak_ugurlu@yahoo.com
- Phone: +905326726533
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.