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

Chronic Pain Clinical Trial

Official title:

Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06082206
• Other study ID #: Pectoral N VS Paravertebral
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Ghada Abo Elfadl
• Phone: 01005802086
• Email: ghadafadl77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Pain
• Lymphedema
• Mastectomy; Lymphedema
• Paravertebral Block

Intervention

Procedure:
• thoracic paravertebral block (TPVB)
Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.
• PECS group
entering the plane between the pectoralis minor muscle and serratus anterior muscle, and bupivacaine 0.25% 10 ml was deposited in this space

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163. — View Citation

Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29. — View Citation

Simpson J, Ariyarathenam A, Dunn J, Ford P. Breast surgery using thoracic paravertebral blockade and sedation alone. Anesthesiol Res Pract. 2014;2014:127467. doi: 10.1155/2014/127467. Epub 2014 Aug 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of chronic pain	The incidence of chronic pain, 0 to 10 Numerical Rating scale (NRS) 3 and 6 months after breast surgery.	3 and 6 months