- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06082206
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy:
March 6, 2026 updated by: Ghada Mohammed AboelFadl, Assiut University
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy: A Randomized Clinical 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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ghada Abo Elfadl
- Phone Number: 01005802086
- Email: ghadafadl77@gmail.com
Study Locations
-
-
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Asyut, Egypt, 715715
- Recruiting
- Assiut governorate
-
Contact:
- Ghada M Aboelfadl, MD
- Phone Number: 01005802086
- Email: ghadafadl77@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TPVB Group
Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.
|
Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.
|
|
Experimental: PECS Group
10 mL of 0.25% bupivacaine between the pectoralis major and minor muscles.
and 20 mL of 0.25% bupivacaine between the pectoralis minor and serratus anterior muscles at the level of the 4th rib.
|
entering the plane between the pectoralis minor muscle and serratus anterior muscle, and bupivacaine 0.25% 20 ml was deposited in this space
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of chronic pain
Time Frame: 3 and 6 months
|
The incidence of chronic pain, with a Douleur Neuropathique 4 (DN4) questionnaire score ≥ 4, indicating neuropathic pain.
|
3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2023
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
October 9, 2023
First Submitted That Met QC Criteria
October 9, 2023
First Posted (Actual)
October 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 9, 2026
Last Update Submitted That Met QC Criteria
March 6, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pectoral N VS Paravertebral
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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