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Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serratus anterior plane block
Transversus thoracic plane block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring serratus anterior plane block, transversus thoracic plane block, post-mastectomy pain

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult female patients > 30 years old, ASA "American Society of Anaesthesiologists" physical status I or II undergoing any unilateral mastectomy.

Exclusion Criteria:

  • Patient's refusal.
  • Known contraindications to regional blocks, including local skin infections,and coagulopathy.
  • Allergies to the local anaesthetics used.

Sites / Locations

  • South Egypt Cancer Institute, Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SAP block for management of post-mastectomy pain

TTP block combined with SAP block for post-mastectomy pain

Arm Description

the patients in this group shall undergo Serraturs anterior plane block for management of post-mastectomy pain.

the patients in this group shall undergo combined Serraturs anterior plane block, and Transversus thoracic plane block for management of post-mastectomy pain.

Outcomes

Primary Outcome Measures

Total sum of used IV additional opioid analgesia.
If the patient experiences a pain of > 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3. the total morphine dose for the post-operative 24 hours will be compared between the case and control group, in order to determine which technique provided more analgesia.

Secondary Outcome Measures

Post-operative pain score
VAS (Visual Analogue Scale, 0-100 mm; where 0 = no pain, and 100 = worst imaginable pain) will be assessed, at rest, per hour for 24 hours post operatively. Moreover, VAS will also be assessed at 12 and 24 hours post-operatively while abducting the ipsilateral arm. If the patient experiences a pain of > 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3.

Full Information

First Posted
May 1, 2020
Last Updated
June 1, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04375111
Brief Title
Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.
Official Title
Comparison Between Serratus Anterior Plane Block, and Transversus Thoracic Plane Block Combined With Serratus Anterior Plane Block, for the Management of Post-mastecomy Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

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

5. Study Description

Brief Summary
a comparison shall be conducted between Serratus anterior plane block, on one hand, and transversus thoracic plane block combined with Serratus anterior plane block, on the other hand for management of post-mastectomy pain. VAS "Visual Analogue Scale" score will be compared in both case, and control groups.
Detailed Description
Breast cancer is one of the most common cancers in women all over the world. In the united states, according to the CDC "Center of Disease Control", it's the second most common cancer occurring in women. Perioperative pain after breast surgeries remains to be taken lightly due to the minimal invasiveness of breast surgeries. However, it is estimated that 25-60% of patients undergoing breast cancer related surgeries develop chronic pain. Acute post-operative pain remains an important risk factor in developing chronic post-mastectomy pain; about 40% of women will have acute post-operative pain, on the other hand, 50% will have chronic pain. Different regional anaesthesia techniques have achieved better management of post-breast surgery acute pain and subsequently less frequent chronic pain. Add to that, effective regional anaesthesia will decrease both the surgical stress response and the requirements of general anaesthetics and opioids, which will keep the function of the immune system intact. A lot of regional anaesthesia techniques have been used to control anterior chest wall pain as the pectoral nerves (PECs) block, paravertebral block, intercostal nerve blocks, thoracic epidural analgesia, serratus anterior plane block. The breast receives its innervation through the anterior and lateral cutaneous branches of the 2nd to the 6th intercostal nerves. Targeting the serratus plane is a safer and a simpler procedure than multiple intercostal or paravertebral blocks. As a setback for the serratus anterior plane block, it only blocks the lateral cutaneous branches of the intercostal nerves with minimal if any effect on the anterior cutaneous branches. The serratus anterior plane block, being unable to block the anterior cutaneous branches of the intercostal nerves, have to be combined with another technique, transversus thoracic plane block, which can block them. The investigators here are trying to measure the efficacy of the combined serratus anterior plane block and tranversus thoracic plane block on the management of post-mastectomy pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
serratus anterior plane block, transversus thoracic plane block, post-mastectomy pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAP block for management of post-mastectomy pain
Arm Type
Active Comparator
Arm Description
the patients in this group shall undergo Serraturs anterior plane block for management of post-mastectomy pain.
Arm Title
TTP block combined with SAP block for post-mastectomy pain
Arm Type
Active Comparator
Arm Description
the patients in this group shall undergo combined Serraturs anterior plane block, and Transversus thoracic plane block for management of post-mastectomy pain.
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Other Intervention Name(s)
SAP block
Intervention Description
•Serratus anterior plane block will be carried out with the patient lying in the lateral position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 5th and 6th ribs in the mid axillary region, for identification of the superficial latissimus dorsi muscles and deep anterior serratus muscles. Then, 25 ml of isobaric bupivacaine 0.25% will be injected above the serratus anterior muscle.
Intervention Type
Procedure
Intervention Name(s)
Transversus thoracic plane block
Other Intervention Name(s)
TTP block
Intervention Description
•Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of isobaric bupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
Primary Outcome Measure Information:
Title
Total sum of used IV additional opioid analgesia.
Description
If the patient experiences a pain of > 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3. the total morphine dose for the post-operative 24 hours will be compared between the case and control group, in order to determine which technique provided more analgesia.
Time Frame
24 hours post-operatively
Secondary Outcome Measure Information:
Title
Post-operative pain score
Description
VAS (Visual Analogue Scale, 0-100 mm; where 0 = no pain, and 100 = worst imaginable pain) will be assessed, at rest, per hour for 24 hours post operatively. Moreover, VAS will also be assessed at 12 and 24 hours post-operatively while abducting the ipsilateral arm. If the patient experiences a pain of > 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3.
Time Frame
24 hours post-operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult female patients > 30 years old, ASA "American Society of Anaesthesiologists" physical status I or II undergoing any unilateral mastectomy. Exclusion Criteria: Patient's refusal. Known contraindications to regional blocks, including local skin infections,and coagulopathy. Allergies to the local anaesthetics used.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zein El-Abdeen Z Hassan, Professor
Organizational Affiliation
Assiut University Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Montasser A Mohamed, A.Professor
Organizational Affiliation
South Egypt Cancer Institute, Assiut University Hospitals.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed H Othman, A.Professor
Organizational Affiliation
South Egypt Cancer Institute, Assiut University Hospitals.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed W Mohamed Shamsedine, MBBCH
Organizational Affiliation
South Egypt Cancer Institute, Assiut University Hospitals.
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
the decision shall be taken at the end of the study. I anticipate that it is going to be a "yes".
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Links:
URL
https://www.cdc.gov/cancer/breast/statistics/
Description
a link for center of disease control, from which the incidence of breast cancer in U.S. was obtained.

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Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.

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