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

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacaine 0.25% with epinephrine

• Registration Number: NCT02946294
• Lead Sponsor: Cairo University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-23
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Status Verified: 2017-12
• Primary Completion: 2017-12-04
• Study Completion: 2017-12-11
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
serratus plane block	Bupivacaine 0.25% with epinephrine	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.
modified pectoral nerves block	Bupivacaine 0.25% with epinephrine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean arterial blood pressure	Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative	Hemodynamics
Heart rate	Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative	Hemodynamics
Time to first requirement of rescue analgesia	The first 24 hours postoperative
Sedation score	Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative	as a side effect of morphine
Nausea and vomiting	The first 24 hours postoperative	as a side effect of morphine
Respiratory rate	Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative	respiratory depression defined as respiratory rate \<12 breaths per minute
Patient satisfaction with postoperative analgesia	One week after surgery	using numerical rating scale from 0 to 10

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Misr Al Qadimah, Egypt