NCT07460115

Brief Summary

To compare mean duration of postoperative analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 4, 2026

Last Update Submit

March 7, 2026

Conditions

Modified Radical Mastectomy

Keywords

magnesium sulphatebupivacainemodified radical mastectomy

Outcome Measures

Primary Outcomes (1)

  • post-operative analgesia

    There is a difference in mean duration of analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.

    20 minutes

Study Arms (2)

Group bupivacaine

ACTIVE COMPARATOR

20 ml of 0.25% bupivacaine

Drug: Group B (bupivacaine)

Group BMG(bupivacaine plus magnesium sulfate)

EXPERIMENTAL

20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate

Drug: Bupivacaine plus magnesium sulfate

Interventions

Group B (bupivacaine)DRUG

receive 20 ml of 0.25% bupivacaine on the operated side for the Erector Spinae Plane (ESP) block.

Also known as: Group bupivacaine
Group bupivacaine
Bupivacaine plus magnesium sulfateDRUG

20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate on each side.

Group BMG(bupivacaine plus magnesium sulfate)

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients having ASA 1 and Il being aged 2 5 - 60 years and undergoing one sided breast cancer surgery \* Patients who sign written informed consent to participate in the study.

You may not qualify if:

  • Patients having contraindications for regional blocks (c.g., infection a t the injection site, coagulopathy), allergy to the drugs used i n the study Patients who received radiotherapy, and patients need axillary dissection • Patients with known hypersensitivity to local anesthetic drug (Bupivacaine). Patients with coagulation disorders or receiving anti-coagulant therapy (INR\>2.0).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulab Devi Hospital Ferozpur Road Lahore

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Interventions

BupivacaineMagnesium Sulfate

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduation Resident

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

May 28, 2025

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

PA(1)