NCT06873893

Brief Summary

The aim of the study is to compare the effectiveness of ultrasound guided pectoral nerve block versus mid-point transverse process block for postoperative analgesia in patients undergoing modified radical mastectomy

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
Last Updated

March 13, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 16, 2025

Last Update Submit

March 7, 2025

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • the time to first rescue analgesia for every patient

    when the patients with numeric rating scale 4 or more will receive 5mg morphine IV as rescue analgesia (the higher numeric rate score means a worse outcome)

    Up to 18 hours after surgery , time between end of operation and when patients ask for rescue analgesia with NRS 4 or more

Secondary Outcomes (3)

  • -Number of patients requested rescue analgesia

    18 hour postoperative

  • The total number of doses of rescue analgesia

    18 hours postoperatively

  • Incidence of complications

    18 hours postoperatively

Study Arms (2)

pectoral nerve block group

ACTIVE COMPARATOR

This group will receive a volume of 10ml of bupivacaine 0.5% will be injected between the pectoralis major and pectoralis minor muscle then another 10ml bupivacaine will be injected between pectoralis minor and serratus anterior muscle

Procedure: Pectoral Nerve Block

Mid-point transverse process block group

ACTIVE COMPARATOR

This group will receive a volume of 20ml of bupivacaine 0.5% at midpoint of the line between the posterior border of the transverse process of T4 and the pleura ( injection will be deep to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligament )

Procedure: Midpoint transverse process block

Interventions

Midpoint transverse process blockPROCEDURE

This group will receive a volume of 20ml of bupivacaine 0.5% at midpoint of the line between the posterior border of the transverse process of T4 and the pleura ( injection will be deep to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligament )

Mid-point transverse process block group
Pectoral Nerve BlockPROCEDURE

This group will receive a volume of 10ml of bupivacaine 0.5% will be injected between the pectoralis major and pectoralis minor muscle then another 10ml bupivacaine will be injected between pectoralis minor and serratus anterior muscle

pectoral nerve block group

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all female patients undergoing modified radical mastectomy
  • age between 35 to 65

You may not qualify if:

  • patient refusal of procedure or participation in the study
  • duration of operation more than 180 minutes
  • known ASA IV or more
  • local skin infection at site of the block
  • contraindication of local anesthetic infiltration ( history or evidence of coagulopathy , use of anticoagulant or antiplatelet therapy , known allergy of local anethestic (bupivacaine )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams university

Cairo , Abbassya, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

yasmin tarek elshahawy, assistant lecturer

CONTACT

00201150009799Yasminelshahawy@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of anesthesia

Study Record Dates

First Submitted

February 16, 2025

First Posted

March 13, 2025

Study Start

July 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)