NCT03498092

Brief Summary

The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified muscle and considered a true landmark to perform thoracic wall blocks because lateral cutaneous branches of the intercostal nerves pierce it in the mid-axillary line. A local anesthetic (LA) is injected under ultrasound (US) guidance either superficial or deep to serratus anterior muscle providing predictable and relatively long-lasting regional anesthesia, which would be suitable for surgical procedures performed on the chest wall. The linear US probe of frequency (6-13 MHz) is placed over the mid-clavicular region in a sagittal plane.The ribs are counted inferiorly and laterally until the fifth rib in the midaxillary line is identified.The latissimus dorsi, teres major, and serratus muscles are identified.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

April 2, 2018

Last Update Submit

October 20, 2018

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • The time of the first analgesia request

    minutes

    24 hours postoperative

Secondary Outcomes (8)

  • The total analgesic requirements (Ketorolac)

    24 hours postoperative

  • Pain assessed by Visual Analogue Scale

    Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative

  • Amount of fentanyl consumption

    Intraoperative.

  • Mean arterial blood pressure

    intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours

  • Heat rate

    intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours

  • +3 more secondary outcomes

Study Arms (3)

Bupivacaine-Dexmedetomidine group

EXPERIMENTAL

After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline and 1mcg/kg dexmedetomidine in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.

Drug: Bupivacaine-Dexmedetomidine

Bupivacaine group

ACTIVE COMPARATOR

After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.

Drug: Bupivacaine

Saline group

PLACEBO COMPARATOR

This group will serve as a control and blinding group and will receive saline infiltration in the same manner.

Drug: General anesthesia

Interventions

Bupivacaine-DexmedetomidineDRUG

isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline and 1 micro gram/kg dexmedetomidine in a volume of 0.5 ml/kg

Bupivacaine-Dexmedetomidine group
BupivacaineDRUG

isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline in a volume of 0.5 ml/kg

Bupivacaine group
General anesthesiaDRUG

Normal saline in a volume of 0.5 ml/kg

Saline group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients scheduled for unilateral modified radical mastectomy.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of American Society of Anesthesiologists (ASA) grade I - III.
  • Scheduled for unilateral modified radical mastectomy.

You may not qualify if:

  • Patient with the skin infection in the axilla.
  • Allergy to local anesthetics of the amide type.
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Center Mansoura University.

Al Mansurah, DKH, 35516, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineAnesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor of anesthesia and surgical intensive care

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 13, 2018

Study Start

August 8, 2016

Primary Completion

October 8, 2018

Study Completion

October 8, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

EG(1)