Pectoral nerve block versus thoracic paravertebral block to prevent chronic pain after mastectomy
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy: A Randomized Clinical Trial
This trial will test whether a pectoral (PECS) block or a thoracic paravertebral (TPVB) block given during mastectomy better prevents long-term chest, axillary, or arm pain in adult women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | Female |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06082206 on ClinicalTrials.gov |
What this trial studies
Adult women undergoing mastectomy under general anesthesia receive either an ultrasound-guided thoracic paravertebral block (TPVB) or pectoral nerve blocks (PEC I/II) in addition to standard postoperative analgesia, and their pain, shoulder function, and complications are followed after surgery. The trial enrolls patients aged 20–65 with BMI 25–35 and ASA I–III who are having unilateral mastectomy with or without axillary lymph node or sentinel node dissection. Ultrasound guidance is used to increase block accuracy and reduce complications, and outcomes include incidence of chronic post-mastectomy pain as well as acute analgesic effectiveness and adverse events. Follow-up includes postoperative pain assessments and longer-term evaluation for development of chronic pain.
Who should consider this trial
Good fit: Women aged 20–65 years with BMI 25–35 and ASA I–III who are scheduled for unilateral mastectomy (with or without axillary node dissection) are ideal candidates.
Not a fit: Men, pregnant or breastfeeding women, patients with active malignant disease, bilateral or recent ipsilateral breast surgery, life expectancy under two years, or those outside the stated age/BMI/health criteria would not be eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If one block proves superior, patients could have lower rates of chronic post-mastectomy pain, faster recovery, and reduced opioid use.
How similar studies have performed: Previous trials show both TPVB and PECS blocks reduce acute postoperative pain after breast surgery, but evidence is mixed about which approach better prevents chronic post-mastectomy pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA grade I, II, or III female patients in the age group of 20-65 years * with body mass index (BMI) of 25-35 who were undergoing mastectomy with or without axillary lymph node or sentinel lymph node dissection or partial mastectomy (sparing the skin, areola, and nipple) with axillary lymph node dissection Exclusion Criteria: * male sex; patient refusal, * a life expectancy less than 2 yr; * active malignant disease; pregnant or breastfeeding women; * bilateral surgery; ipsilateral breast surgery in the past 3 yr;
Where this trial is running
Asyut
- Assiut governorate — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Ghada Abo Elfadl
- Email: ghadafadl77@gmail.com
- Phone: 01005802086
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.