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AzTrials

Postoperative PainPhase 2NCT02946294

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

A Phase 2 study testing Bupivacaine 0.25% with epinephrine in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Postoperative Pain
What is being tested?
Bupivacaine 0.25% with epinephrine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
Oct 2016to 11 Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • National Cancer Institute

    Cairo, Misr Al Qadimah, 11796

Other trials in Egypt

About this study

Official title: A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

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

Read the detailed description

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.

Being tested
Bupivacaine 0.25% with epinephrine
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine 0.25% with epinephrineDrug

    Also called Markyrene

  • Bupivacaine 0.25% with epinephrineDrug

    Also called Markyrene

Study groups in NCT02946294
Study groupRoleWhat they receive
modified pectoral nerves blockActive comparatorModified 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.
Receives: Drug: Bupivacaine 0.25% with epinephrine
serratus plane blockActive comparatorSerratus 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.
Receives: Drug: Bupivacaine 0.25% with epinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fentanyl consumption

    Measured: Intraoperative

  2. Total morphine consumption

    Measured: The first 24 hours postoperative

  3. Visual analogue scale score at rest and during shoulder movement

    Measured: The first 24 hours postoperative

Secondary outcomes (7)

  1. Mean arterial blood pressure

    Hemodynamics

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

  2. Heart rate

    Hemodynamics

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

  3. Time to first requirement of rescue analgesia

    Measured: The first 24 hours postoperative

  4. Sedation score

    as a side effect of morphine

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

  5. Respiratory rate

    respiratory depression defined as respiratory rate <12 breaths per minute

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

  6. Nausea and vomiting

    as a side effect of morphine

    Measured: The first 24 hours postoperative

  7. Patient satisfaction with postoperative analgesia

    using numerical rating scale from 0 to 10

    Measured: One week after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion4 Dec 2017
  4. Study completion11 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02946294
Sponsor's protocol ID
MD2010014055.3
Other IDs
IRB00004025
Status last verified
Dec 2017
First submitted
23 Oct 2016
Last updated
13 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27687427

  • 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.

    PubMed 27587333

  • 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.

    PubMed 27440171

  • 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.

    PubMed 27413485

  • 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.

    PubMed 27051373

  • 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.

    PubMed 26934607

  • 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.

    PubMed 26603109

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

    PubMed 26437549

  • 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.

    PubMed 26000690

  • 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.

    PubMed 25247916

  • 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.

    PubMed 25039953

  • 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.

    PubMed 27097516

  • 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.

    PubMed 25583191

  • 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.

    PubMed 25376971

  • 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.

    PubMed 25302976

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bupivacaine 0.25% with epinephrine in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fentanyl consumption (time frame: Intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02946294, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.

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