NCT02946294

Brief Summary

The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 postoperative-pain

Timeline
Completed

Started Oct 2016

Typical duration for phase_2 postoperative-pain

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

Study Start

First participant enrolled

October 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2017

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

October 23, 2016

Last Update Submit

December 12, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

  • Fentanyl consumption

    Intraoperative

  • Total morphine consumption

    The first 24 hours postoperative

  • Visual analogue scale score at rest and during shoulder movement

    The first 24 hours postoperative

Secondary Outcomes (7)

  • Mean arterial blood pressure

    Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative

  • Heart rate

    Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative

  • Time to first requirement of rescue analgesia

    The first 24 hours postoperative

  • Sedation score

    Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative

  • Respiratory rate

    Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative

  • +2 more secondary outcomes

Study Arms (2)

modified pectoral nerves block

ACTIVE COMPARATOR

Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles.

Drug: Bupivacaine 0.25% with epinephrine

serratus plane block

ACTIVE COMPARATOR

Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs.

Drug: Bupivacaine 0.25% with epinephrine

Interventions

Bupivacaine 0.25% with epinephrineDRUG
Also known as: Markyrene
modified pectoral nerves block

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).

You may not qualify if:

  • Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index\> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Cairo, Misr Al Qadimah, 11796, Egypt

Location

Related Publications (17)

  • Hards M, Harada A, Neville I, Harwell S, Babar M, Ravalia A, Davies G. The effect of serratus plane block performed under direct vision on postoperative pain in breast surgery. J Clin Anesth. 2016 Nov;34:427-31. doi: 10.1016/j.jclinane.2016.05.029. Epub 2016 Jun 16.

    PMID: 27687427BACKGROUND

  • 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

  • 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

  • Okmen K, Okmen BM, Uysal S. Serratus Anterior Plane (SAP) Block Used for Thoracotomy Analgesia: A Case Report. Korean J Pain. 2016 Jul;29(3):189-92. doi: 10.3344/kjp.2016.29.3.189. Epub 2016 Jul 1.

    PMID: 27413485BACKGROUND

  • Daga V, Narayanan MK, Dedhia JD, Gaur P, Crick H, Gaur A. Cadaveric feasibility study on the use of ultrasound contrast to assess spread of injectate in the serratus anterior muscle plane. Saudi J Anaesth. 2016 Apr-Jun;10(2):198-201. doi: 10.4103/1658-354X.168825.

    PMID: 27051373BACKGROUND

  • Khemka R, Chakraborty A, Ahmed R, Datta T, Agarwal S. Ultrasound-Guided Serratus Anterior Plane Block in Breast Reconstruction Surgery. A A Case Rep. 2016 May 1;6(9):280-2. doi: 10.1213/XAA.0000000000000297.

    PMID: 26934607BACKGROUND

  • Bhoi D, Pushparajan HK, Talawar P, Kumar A, Baidya DK. Serratus anterior plane block for breast surgery in a morbidly obese patient. J Clin Anesth. 2016 Sep;33:500-1. doi: 10.1016/j.jclinane.2015.09.004. Epub 2015 Oct 23. No abstract available.

    PMID: 26603109BACKGROUND

  • Ohgoshi Y, Yokozuka M, Terajima K. [Serratus-Intercostal Plane Block for Brest Surgery]. Masui. 2015 Jun;64(6):610-4. Japanese.

    PMID: 26437549BACKGROUND

  • Madabushi R, Tewari S, Gautam SK, Agarwal A, Agarwal A. Serratus anterior plane block: a new analgesic technique for post-thoracotomy pain. Pain Physician. 2015 May-Jun;18(3):E421-4.

    PMID: 26000690BACKGROUND

  • Kunhabdulla NP, Agarwal A, Gaur A, Gautam SK, Gupta R, Agarwal A. Serratus anterior plane block for multiple rib fractures. Pain Physician. 2014 Sep-Oct;17(5):E651-3. No abstract available.

    PMID: 25247916BACKGROUND

  • Eid M. Other potential uses of serratus anterior plane block. Anaesthesia. 2014 Aug;69(8):933-4. doi: 10.1111/anae.12778. No abstract available.

    PMID: 25039953BACKGROUND

  • Kikuchi M, Takaki S, Nomura T, Goto T. [Difference in the Spread of Injectate between Ultrasound Guided Pectoral Nerve Block I and II. A Cadaver Study]. Masui. 2016 Mar;65(3):314-7. Japanese.

    PMID: 27097516BACKGROUND

  • Tan YR, Quek KH. Tackling the axillary blind spot with PECS II. Anaesthesia. 2015 Feb;70(2):230-1. doi: 10.1111/anae.13005. No abstract available.

    PMID: 25583191BACKGROUND

  • 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

  • Purcell N, Wu D. Novel use of the PECS II block for upper limb fistula surgery. Anaesthesia. 2014 Nov;69(11):1294. doi: 10.1111/anae.12876. No abstract available.

    PMID: 25302976BACKGROUND

  • 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.

    PMID: 22939099BACKGROUND

  • Bakeer AH, Kamel KM, Abdelgalil AS, Ghoneim AA, Abouel Soud AH, Hassan ME. Modified Pectoral Nerve Block versus Serratus Block for Analgesia Following Modified Radical Mastectomy: A Randomized Controlled Trial. J Pain Res. 2020 Jul 14;13:1769-1775. doi: 10.2147/JPR.S252539. eCollection 2020.

    PMID: 32765052DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ayman A Ghoneim, MD

    National Cancer Institute, Cairo University

    STUDY DIRECTOR

  • Ahmad H Aboul Soud, MD

    National Cancer Institute, Cairo University

    STUDY CHAIR

  • Khaled M Salem, Master

    National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

  • Mohamed E Hassan, MD

    National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

  • Ahmad H Mohamed, MD

    National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesia and Pain Relief

Study Record Dates

First Submitted

October 23, 2016

First Posted

October 27, 2016

Study Start

October 1, 2016

Primary Completion

December 4, 2017

Study Completion

December 11, 2017

Last Updated

December 13, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)