NCT06016205

Brief Summary

50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery, Will be included in the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 29, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

April 29, 2023

Last Update Submit

September 8, 2023

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

  • post-operative analgesia.

    the visual analog score will be evaluated postoperatively in all the patients in both groups

    he visual analog score will be evaluated every 1 hour postoperatively.

Study Arms (2)

Morphine group (n= 25):

ACTIVE COMPARATOR
Procedure: intrathecal morphine injection

PECS group (n= 25):

ACTIVE COMPARATOR
Procedure: ultrasound guided PECS2 block

Interventions

intrathecal morphine injectionPROCEDURE

Patients will receive intrathecal 200 microgram morphine immediately before induction of general anesthesia

Morphine group (n= 25):
ultrasound guided PECS2 blockPROCEDURE

ultrasound guided PECS2 block will be performed with 30 ml bupivacaine 0.25%

PECS group (n= 25):

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery.

You may not qualify if:

  • \- Patient refusal.
  • Patient with significant neurological , psychiatric or neuromuscular disease
  • Alcoholism. Drug abuse.
  • Pregnancy or lactating women.
  • Suspected Coagulopathy.
  • Morbid obesity.
  • Known allergy to study medications.
  • local infection at the block site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Mohammed Ahmed Mahmoud, MD

CONTACT

01091328413mohamedmahmoud@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

April 29, 2023

First Posted

August 29, 2023

Study Start

December 1, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

EG(1)