About this trial
Chronic pain after Mastectomy is frequent and an important healthcare priority because of its effect on quality of life. Although the association between the severity of acute pain after surgery and the likelihood of chronic pain is known, their causal relationship has not been clarified. Mastectomy, frequently done for the management of breast cancer, is associated with significant acute postoperative pain and limited shoulder movement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
thoracic paravertebral block (TPVB)
Procedure/SurgeryBupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.
PECS group
Procedure/Surgeryentering the plane between the pectoralis minor muscle and serratus anterior muscle, and bupivacaine 0.25% 20 ml was deposited in this space
Treatment groups
Trial outcomes
Primary outcomes
The incidence of chronic pain
The incidence of chronic pain, with a Douleur Neuropathique 4 (DN4) questionnaire score ≥ 4, indicating neuropathic pain.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.