Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

NCT ID: NCT02946294

Last Updated: 2017-12-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

modified pectoral nerves block

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25% with epinephrine

Intervention Type DRUG

serratus plane block

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25% with epinephrine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine 0.25% with epinephrine

Intervention Type DRUG

Bupivacaine 0.25% with epinephrine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Markyrene Markyrene

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Khaled Mostafa Kamel

Assistant Lecturer of Anesthesia and Pain Relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayman A Ghoneim, MD

Role: STUDY_DIRECTOR

National Cancer Institute, Cairo University

Ahmad H Aboul Soud, MD

Role: STUDY_CHAIR

National Cancer Institute, Cairo University

Khaled M Salem, Master

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Cairo University

Mohamed E Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Cairo University

Ahmad H Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Institute

Cairo, Misr Al Qadimah, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27687427 (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)

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)

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.

Reference Type BACKGROUND
PMID: 27413485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27051373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26934607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26603109 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26437549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26000690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25247916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25039953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27097516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25583191 (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)

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.

Reference Type BACKGROUND
PMID: 25302976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22939099 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32765052 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00004025

Identifier Type: OTHER

Identifier Source: secondary_id

MD2010014055.3

Identifier Type: -

Identifier Source: org_study_id