Adding Morphine to ESP Block in Management of Acute PMP

NCT06175741 | Not Yet Recruiting

• 1 other identifier: ESP block with morphine in PMP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to determine the efficacy of adding morphine in two doses (3mg, 5mg) to erector spinae plane block in relieving acute post mastectomy pain

Conditions

Acute Post-mastectomy Pain Treatment

Outcome Measures

Primary Outcomes (1)

• total morphine consumption

  . If the VAS score more than 3 rescue postoperative analgesia in the form of PCA morphine with initial bolus of 0.1mg/kg will be administered once the patient exhibit pain , followed by a 1 mg bolus with a locked period of 15 minutes when no background infusion will be permitted, total amount of morphine will be consumed be the patient will be recorded.

  during 24 hours post operative

Secondary Outcomes (7)

• Time of first analgesic request

  2,4,6,8,12,24 hours post operative

• VAS at rest and movement

  2,4,6,8,12,24 hours post operative

• Mean blood pressure (MBP)

  Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative

• Number of participants with morphine side effects

  2,4,6,8,12,24 hours post operative

• Ramsay sedation scale

  2,4,6,8,12,24 hours post operative

Study Arms (3)

Control group

PLACEBO COMPARATOR

this group will receive erector spinae plane block only(bupivicaine)

Procedure: erector spinae plane block

Interventional 3mg

EXPERIMENTAL

this group will receive erector spinae plane block (bupivicaine and 3mg morphine)

Procedure: erector spinae plane block

Interventional 5mg

EXPERIMENTAL

this group will receive erector spinae plane block (bupivicaine and 5mg morphine)

Procedure: erector spinae plane block

Interventions

erector spinae plane block PROCEDURE

The ultrasound (US)-guided ESP block will be provided while the patient be in a seated position according to surgical site (right or left). Using high-frequency linear US transducer , the probe is placed in the longitudinal orientation lateral to thoracic third and six spinous processes ,then the trapezius muscle ,rhomboids major muscle and erector spinae muscle are identified and we will inject 20ml of 0.25% bupivacaine into interfacial plane below erector spinae muscle in one level (between T3and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group

Control group; Interventional 3mg; Interventional 5mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• /female patients aged from 18 to 60 years.
• /ASA I -II
• /Surgery is modified radical mastectomy

You may not qualify if:

• /ASA more than II
• /Patients with known allergy to study drugs
• /Skin infection at site of needle puncture
• /Coagulopathy
• /Uncooperative patients

Sponsors & Collaborators

• Assiut University: lead

Related Publications (14)

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Study Officials

• shereen Mamdouh

  south Egypt cancer institute ,Assiut university

  STUDY DIRECTOR

Central Study Contacts

Hadir Atef

CONTACT

+201060176410; hadeer.200atef@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invistigator

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 19, 2023
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06