Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy:

Not Applicable

Not yet recruiting

• Conditions: Mastectomy; Lymphedema; Paravertebral Block; Pectoral Nerve Block; Chronic Pain
• Interventions: Procedure: PECS group; Procedure: thoracic paravertebral block (TPVB)

• Registration Number: NCT06082206
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

General anesthesia with postoperative NSAI D and opioids is a commonly used technique for postoperative analgesia after breast surgeries. Patients with mastectomy under general anesthesia commonly have pain in the axilla and upper limb that increases hospital stay, costs, and postoperative complications .Thoracic paravertebral block can be performed for analgesia after breast surgery. Ultrasound usage gave an accurate reading of the depth to the paravertebral space and can be used during the whole technique. Breast surgery is usually done with axillary dissection and can be done at single or multiple levels of thoracic paravertebral blocks .Thoracic paravertebral block is associated with multiple complications such as hypotension, pneumothorax, sympathetic block, central spread of local anesthesia or failed block which may cause limitations in the technique. The use of ultrasound in anesthesia increases the success rate of the block and decreases the incidence of variable complications .On the other hand, many interfascial plane blocks have been described. Pectoral nerve block (PECS) has been described as interfascial plane blocks and provide analgesic adjuvants for breast surgery with or without axillary dissection. The block was described as an injection of local anesthetic between the pectoralis major and minor muscles (PEC I) and between pectoralis minor and serratus anterior muscle (PEC 2) .

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16
• Study Start: 2023-11
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS Group	PECS group	bupivacaine 0.25% 10 ml
TPVB Group	thoracic paravertebral block (TPVB)	Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.

Primary Outcome Measures

Name	Time	Method
The incidence of chronic pain	3 and 6 months	The incidence of chronic pain, 0 to 10 Numerical Rating scale (NRS) 3 and 6 months after breast surgery.

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt