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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06082206
Other study ID # Pectoral N VS Paravertebral
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


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
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