NCT04375111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

May 1, 2020

Last Update Submit

June 1, 2022

Conditions

Pain, Postoperative

Keywords

serratus anterior plane blocktransversus thoracic plane blockpost-mastectomy pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours post-operatively

Secondary Outcomes (1)

  • Post-operative pain score

    24 hours post-operatively

Study Arms (2)

SAP block for management of post-mastectomy pain

ACTIVE COMPARATOR

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

Procedure: Serratus anterior plane block

TTP block combined with SAP block for post-mastectomy pain

ACTIVE COMPARATOR

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

Procedure: Serratus anterior plane blockProcedure: Transversus thoracic plane block

Interventions

Serratus anterior plane blockPROCEDURE

•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.

Also known as: SAP block
SAP block for management of post-mastectomy painTTP block combined with SAP block for post-mastectomy pain
Transversus thoracic plane blockPROCEDURE

•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.

Also known as: TTP block
TTP block combined with SAP block for post-mastectomy pain

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Institute, Assiut University

Asyut, Egypt

Location

Related Publications (16)

  • 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.

    PMID: 24114568BACKGROUND

  • 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.

    PMID: 23580693BACKGROUND

  • 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.

    PMID: 24282410BACKGROUND

  • 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.

    PMID: 16942948BACKGROUND

  • 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.

    PMID: 19903919BACKGROUND

  • 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.

    PMID: 21831090BACKGROUND

  • 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.

    PMID: 25376971BACKGROUND

  • 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.

    PMID: 7487214BACKGROUND

  • 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.

    PMID: 16931684BACKGROUND

  • 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.

    PMID: 419209BACKGROUND

  • 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.

    PMID: 2007101BACKGROUND

  • 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.

    PMID: 27587333BACKGROUND

  • 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.

    PMID: 8785595BACKGROUND

  • 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.

    PMID: 27440171BACKGROUND

  • 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.

    PMID: 26079353BACKGROUND

  • 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.

    PMID: 28203723BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Zein El-Abdeen Z Hassan, Professor

    Assiut University Hospitals

    STUDY CHAIR

  • 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.

    STUDY DIRECTOR

  • Ahmed W Mohamed Shamsedine, MBBCH

    South Egypt Cancer Institute, Assiut University Hospitals.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 5, 2020

Study Start

June 15, 2021

Primary Completion

March 15, 2022

Study Completion

April 30, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Locations

EG(1)