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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946294
• Other study ID #: MD2010014055.3
• Secondary ID: IRB00004025
• Status: Completed
• Phase: Phase 2
• First received: October 23, 2016
• Last updated: December 12, 2017
• Start date: October 2016
• Est. completion date: December 11, 2017

Study information

• Verified date: December 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 11, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine 0.25% with epinephrine

• Bupivacaine 0.25% with epinephrine

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo	Misr Al Qadimah

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Eid M. Other potential uses of serratus anterior plane block. Anaesthesia. 2014 Aug;69(8):933-4. doi: 10.1111/anae.12778. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Tan YR, Quek KH. Tackling the axillary blind spot with PECS II. Anaesthesia. 2015 Feb;70(2):230-1. doi: 10.1111/anae.13005. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl consumption		Intraoperative
Primary	Total morphine consumption		The first 24 hours postoperative
Primary	Visual analogue scale score at rest and during shoulder movement		The first 24 hours postoperative
Secondary	Mean arterial blood pressure	Hemodynamics	Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Secondary	Heart rate	Hemodynamics	Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Secondary	Time to first requirement of rescue analgesia		The first 24 hours postoperative
Secondary	Sedation score	as a side effect of morphine	Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
Secondary	Respiratory rate	respiratory depression defined as respiratory rate <12 breaths per minute	Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
Secondary	Nausea and vomiting	as a side effect of morphine	The first 24 hours postoperative
Secondary	Patient satisfaction with postoperative analgesia	using numerical rating scale from 0 to 10	One week after surgery