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Clinical Trials/NCT05771116
NCT05771116RecruitingNot Applicable

Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial

National Cancer Institute, Egypt2 sites in 1 country70 target enrollmentStarted: January 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups

.70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)

  • All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia
  • Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic

Detailed Description

  • 70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
  • All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA
  • Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic.
  • Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study.
  • An independent observer who was blind to the group assignment checked the intraoperative and postoperative data.
  • VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

An independent observer who will be blind to the group assignment checked the intraoperative and postoperative data also patient will be be blinded also

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •.Physical status ASA II.
  • •. Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia

Exclusion Criteria

  • •.History of psychological disorders.
  • •Known sensitivity or contraindication to local anesthetics.
  • •Localized infection at the site of block.
  • •patients with coagulopathy or an (INR ≥ 2)

Outcomes

Primary Outcomes

Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.

Time Frame: 48 hours postoperative

the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement

Secondary Outcomes

  • 1st request of analgesia(48 hours postoperative)

Investigators

Sponsor
National Cancer Institute, Egypt
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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