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Clinical Trials/NCT02946294
NCT02946294
Completed
Phase 2

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

Cairo University1 site in 1 country90 target enrollmentOctober 2016

Overview

Phase
Phase 2
Intervention
Bupivacaine 0.25% with epinephrine
Conditions
Postoperative Pain
Sponsor
Cairo University
Enrollment
90
Locations
1
Primary Endpoint
Fentanyl consumption
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
December 11, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Khaled Mostafa Kamel

Assistant Lecturer of Anesthesia and Pain Relief

Cairo University

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Bupivacaine 0.25% with epinephrine

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.

Intervention: Bupivacaine 0.25% with epinephrine

Outcomes

Primary Outcomes

Fentanyl consumption

Time Frame: Intraoperative

Total morphine consumption

Time Frame: The first 24 hours postoperative

Visual analogue scale score at rest and during shoulder movement

Time Frame: The first 24 hours postoperative

Secondary Outcomes

  • Nausea and vomiting(The first 24 hours postoperative)
  • 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)
  • Patient satisfaction with postoperative analgesia(One week after surgery)

Study Sites (1)

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