Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy

NCT ID: NCT04732390

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-07-01

Brief Summary

To evaluate the analgesic efficacy of magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute pain management

Detailed Description

The participating female will be randomly allocated using computer generated randomization program (http://www.randoiler.org) into one of 2 groups.

Group (C) / (I):20 patients (control group):

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.

Group (M) / (III): 20 patients (magnesium slphate group):

Patient will receive 20ml 0.25% levobupivacaine above + 0.7 mg/kg MgSo4. The patient, the anesthesiologist who administered the drugs and the data collector will be blinded to the study drugs.

** Study protocol

Pre-operative and post-operative procedure:

Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery, ECG, temperature and capnography), an intravenous cannula will be placed and secured.

Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle, are identified from surface, we deposite20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.

General anesthesia will be induced with fentanyl l μg /kg, propofol 2mg /kg, muscle relaxant (atracurium 0.5 mg/kg) inhalational anesthesia (isoflurane or sevoflurane) No other narcotic, analgesic or sedative will be administrated during operative period.

Standard monitor (mean arterial blood pressure, heart rate , oxygen saturation & end-tidal Co2) will observed and recorded every 30 min till end of surgery

Post-operative:

The patient will be transferred to the post anesthesia care unit (PACU) and will be monitored for:

1. Vital signs (heart rate, noninvasive blood pressure, and oxygen saturation).

2. RASS score (Richmond Agitation & Sedation scale) with its +4:-5 score range will be used to assess sedation post-operative, considered sedation ≥-2 table (1)

3. Numerical Rating Score (NRS) pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2, 4, 6, 8, 12,18and 24hour in the post-operative period figure (1).

4. Time and amount to request analgesia (PCA patient controlled analgesia morphine (demand dose 1-2 mg, lock out 6-10 min)) at NRS≥3.

5. Side effect of studied drugs as (hypotension, sedation , respiration depression and vomiting ) and complication of the block for 24h post- operative.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GROUP(A) (CONTROL GROUP)

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.

Group Type: PLACEBO_COMPARATOR

erector spinae block with bupivacaine

Intervention Type: PROCEDURE

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5

Group (M)

Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5. .

Group Type: ACTIVE_COMPARATOR

erector spinae block with bupivacaine and magnesium sulphate

Intervention Type: PROCEDURE

Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.

Interventions

erector spinae block with bupivacaine

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5

Intervention Type: PROCEDURE

erector spinae block with bupivacaine and magnesium sulphate

Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• female patient
• American society of anesthesiologists (ASA) I and II physical status
• age from 25 to 70 years old
• scheduled for either left or right modified radical mastectomy (MRM)

Exclusion Criteria

• infection of the skin at or near site of needle puncture
• coagulopathy,
• drug hypersensitivity or allergy to the studied drugs,
• central or peripheral neuropathy,
• significant organ dysfunction cardiac dysrrhythmias,
• obesity (BMI>35kg/m2)
• recently use analgesic drugs

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

South Egypt Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Peter Rafaat Edward Iskander

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

peter R Edward, MSc

Role: PRINCIPAL_INVESTIGATOR

specialist

Locations

South Egypt Cancer Institute

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

peter R Edward, MSc

Role: CONTACT

Peter_rafaat85@yahoo.com

1224083376 ext. 0020

Facility Contacts

peter R Edward, MSc

Role: primary

Peter_rafaat85@yahoo.com

1224083376 ext. 0020

Other Identifiers

peter 2 SECI

Identifier Type: -

Identifier Source: org_study_id