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

NCT ID: NCT04375111

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Serratus anterior plane block

Intervention Type PROCEDURE

•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.

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.

Group Type ACTIVE_COMPARATOR

Serratus anterior plane block

Intervention Type PROCEDURE

•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.

Transversus thoracic plane block

Intervention Type PROCEDURE

•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.

Interventions

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Serratus anterior plane block

•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

Transversus thoracic plane block

•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.

Intervention Type PROCEDURE

Other Intervention Names

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SAP block TTP block

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed wahby Shamsedine

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zein El-Abdeen Z Hassan, Professor

Role: STUDY_CHAIR

Assiut University Hospitals

Montasser A Mohamed, A.Professor

Role: STUDY_DIRECTOR

South Egypt Cancer Institute, Assiut University Hospitals.

Ahmed H Othman, A.Professor

Role: STUDY_DIRECTOR

South Egypt Cancer Institute, Assiut University Hospitals.

Ahmed W Mohamed Shamsedine, MBBCH

Role: PRINCIPAL_INVESTIGATOR

South Egypt Cancer Institute, Assiut University Hospitals.

Locations

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South Egypt Cancer Institute, Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 23580693 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 16942948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19903919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21831090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25376971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7487214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16931684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 419209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2007101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27587333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8785595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27440171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26079353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28203723 (View on PubMed)

Other Identifiers

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post-mastectomy pain control

Identifier Type: -

Identifier Source: org_study_id

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