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

Primary Purpose

Paravertebral Block, Pectoral Nerve Block, Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thoracic paravertebral block (TPVB)
PECS group
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paravertebral Block

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Assiut governorate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TPVB Group

PECS Group

Arm Description

Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.

bupivacaine 0.25% 10 ml

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2023
Last Updated
October 13, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT06082206
Brief Title
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy:
Official Title
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paravertebral Block, Pectoral Nerve Block, Chronic Pain, Mastectomy; Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPVB Group
Arm Type
Experimental
Arm Description
Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.
Arm Title
PECS Group
Arm Type
Experimental
Arm Description
bupivacaine 0.25% 10 ml
Intervention Type
Procedure
Intervention Name(s)
thoracic paravertebral block (TPVB)
Intervention Description
Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.
Intervention Type
Procedure
Intervention Name(s)
PECS group
Intervention Description
entering the plane between the pectoralis minor muscle and serratus anterior muscle, and bupivacaine 0.25% 10 ml was deposited in this space
Primary Outcome Measure Information:
Title
The incidence of chronic pain
Description
The incidence of chronic pain, 0 to 10 Numerical Rating scale (NRS) 3 and 6 months after breast surgery.
Time Frame
3 and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada Abo Elfadl
Phone
01005802086
Email
ghadafadl77@gmail.com
Facility Information:
Facility Name
Assiut governorate
City
Assiut
ZIP/Postal Code
715715
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25376971
Citation
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.
Results Reference
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PubMed Identifier
22939099
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.
Results Reference
background
PubMed Identifier
25214832
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.
Results Reference
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Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy:

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