- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04375111
Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.
June 1, 2022 updated by: Ahmed wahby Shamsedine, Assiut University
Comparison Between Serratus Anterior Plane Block, and Transversus Thoracic Plane Block Combined With Serratus Anterior Plane Block, for the Management of Post-mastecomy Pain.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
54
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 Locations
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Assiut, Egypt
- South Egypt Cancer Institute, Assiut University
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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
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SAP block for management of post-mastectomy pain
the patients in this group shall undergo Serraturs anterior plane block for management of post-mastectomy pain.
|
•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.
Other Names:
|
Active Comparator: TTP block combined with SAP block for 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.
|
•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.
Other Names:
•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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total sum of used IV additional opioid analgesia.
Time Frame: 24 hours post-operatively
|
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.
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24 hours post-operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain score
Time Frame: 24 hours post-operatively
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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.
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24 hours post-operatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Zein El-Abdeen Z Hassan, Professor, Assiut university hospitals
- Study Director: Montasser A Mohamed, A.Professor, South Egypt Cancer Institute, Assiut University Hospitals.
- Study Director: Ahmed H Othman, A.Professor, South Egypt Cancer Institute, Assiut University Hospitals.
- Principal Investigator: Ahmed W Mohamed Shamsedine, MBBCH, South Egypt Cancer Institute, Assiut University Hospitals.
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
- Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
- 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.
- Lynch EP, Welch KJ, Carabuena JM, Eberlein TJ. Thoracic epidural anesthesia improves outcome after breast surgery. Ann Surg. 1995 Nov;222(5):663-9. doi: 10.1097/00000658-199511000-00009.
- Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
- Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007.
- Mayes J, Davison E, Panahi P, Patten D, Eljelani F, Womack J, Varma M. An anatomical evaluation of the serratus anterior plane block. Anaesthesia. 2016 Sep;71(9):1064-9. doi: 10.1111/anae.13549. Epub 2016 Jul 20.
- Kairaluoma PM, Bachmann MS, Rosenberg PH, Pere PJ. Preincisional paravertebral block reduces the prevalence of chronic pain after breast surgery. Anesth Analg. 2006 Sep;103(3):703-8. doi: 10.1213/01.ane.0000230603.92574.4e.
- DeSantis C, Ma J, Bryan L, Jemal A. Breast cancer statistics, 2013. CA Cancer J Clin. 2014 Jan-Feb;64(1):52-62. doi: 10.3322/caac.21203. Epub 2013 Oct 1.
- Mejdahl MK, Andersen KG, Gartner R, Kroman N, Kehlet H. Persistent pain and sensory disturbances after treatment for breast cancer: six year nationwide follow-up study. BMJ. 2013 Apr 11;346:f1865. doi: 10.1136/bmj.f1865.
- Hirko KA, Soliman AS, Hablas A, Seifeldin IA, Ramadan M, Banerjee M, Harford JB, Chamberlain RM, Merajver SD. Trends in Breast Cancer Incidence Rates by Age and Stage at Diagnosis in Gharbiah, Egypt, over 10 Years (1999-2008). J Cancer Epidemiol. 2013;2013:916394. doi: 10.1155/2013/916394. Epub 2013 Oct 24.
- Huang TT, Parks DH, Lewis SR. Outpatient breast surgery under intercostal block anesthesia. Plast Reconstr Surg. 1979 Mar;63(3):299-303. doi: 10.1097/00006534-197903000-00001.
- Atanassoff PG, Alon E, Pasch T, Ziegler WH, Gautschi K. Intercostal nerve block for minor breast surgery. Reg Anesth. 1991 Jan-Feb;16(1):23-7.
- Zocca JA, Chen GH, Puttanniah VG, Hung JC, Gulati A. Ultrasound-Guided Serratus Plane Block for Treatment of Postmastectomy Pain Syndromes in Breast Cancer Patients: A Case Series. Pain Pract. 2017 Jan;17(1):141-146. doi: 10.1111/papr.12482. Epub 2016 Sep 2.
- Sarhadi NS, Shaw Dunn J, Lee FD, Soutar DS. An anatomical study of the nerve supply of the breast, including the nipple and areola. Br J Plast Surg. 1996 Apr;49(3):156-64. doi: 10.1016/s0007-1226(96)90218-0.
- Ueshima H, Kitamura A. Blocking of Multiple Anterior Branches of Intercostal Nerves (Th2-6) Using a Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388. doi: 10.1097/AAP.0000000000000245. No abstract available.
- Ueshima H, Otake H. RETRACTED: Addition of transversus thoracic muscle plane block to pectoral nerves block provides more effective perioperative pain relief than pectoral nerves block alone for breast cancer surgery. Br J Anaesth. 2017 Mar 1;118(3):439-443. doi: 10.1093/bja/aew449. No abstract available.
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)
June 15, 2021
Primary Completion (Actual)
March 15, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
May 1, 2020
First Submitted That Met QC Criteria
May 4, 2020
First Posted (Actual)
May 5, 2020
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- post-mastectomy pain control
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
the decision shall be taken at the end of the study.
I anticipate that it is going to be a "yes".
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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