Postoperative Anelgesic Effect of Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block

NCT05452369 | Unknown

• 1 other identifier: MFM-IRB,MS.21.09.1654
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

Despite of analgesic effect of intravenous analgesic medications at intraoperative and postoperative time , The regional anesthetic techniquehas more benefits suchbetter control of Acute pain and hence less chronic pain and decreases the need for opioids and analgesics to preserve immune function which responsible for higher rates of infection and local recurrence, even metastasis . New regional anesthetic technique for modified radical mastectomy discovered recently called rhomboid intercostal nerve block that will compared against erector spinae plane block .

Conditions

Post Operative Pain

Keywords

Modified Radical Mastectomy; Rhomboid Intercostal Nerve Block; Erector Spinae Plane Block .

Outcome Measures

Primary Outcomes (1)

• The total analgesic requirements during the first 24 hours postoperative.

  All patients will receive standard postoperative analgesia (1gm paracetamol every 8 hours IV).

  0,2,4,6,8,10,12,16,20,24 hours postoperatively

Secondary Outcomes (1)

• The duration of effective analgesia

  0,2,4,6,8,10,12,16,20,24 hours postoperatively

Study Arms (2)

rhomboid intercostal plane block

EXPERIMENTAL

as in intervention description

Drug: Rhomboid intercostal plane block

Erector spinae plane block

EXPERIMENTAL

As in intervention description

Drug: Rhomboid intercostal plane block

Interventions

Rhomboid intercostal plane block DRUG

\- 30 mL bupivacaine 0.25% will injected ultrasound-guided in rhomboid intercostal fascial plane .

Also known as: fascial plane block

Erector spinae plane block; rhomboid intercostal plane block

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: Female patients undergoing modified radical mastectomy surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Female patients aged between 25-65 years.
• ASA physical status I or II.
• Scheduled for elective unilateral modified radical mastectomy

You may not qualify if:

• \- Patient refusal.
• Infection at the site of injection.
• Hypersensitivity to the local anesthetic
• Bleeding disorders.
• Patients with cardiac, hepatic, and renal failure.
• BMI ≥40 kg/m2
• Patient with serum cr \> 1.5

Sponsors & Collaborators

• ghada fouad: lead

Study Sites (2)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• mohamed y makharita, MD

  Professor OFanesthesia Mansoura university

  STUDY DIRECTOR

• ghada f amer, MD

  Assistant professor of anesthesia Mansoura university

  STUDY CHAIR

• ahmed E Kamal, resident

  resident of anesthesia mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: \- double-blind comparative study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor of anesthesia

Model Details: \- Two arms: rhomboid intercostal plane block is the first group Erector spinae plane block is the second group

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: October 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

EG (2)