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

Primary Purpose

Acute Pain

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
erector spinae block with bupivacaine
erector spinae block with bupivacaine and magnesium sulphate
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pain

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • South Egypt Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

GROUP(A) (CONTROL GROUP)

Group (M)

Arm Description

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

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

Outcomes

Primary Outcome Measures

analgesia request
first request for analgesia .

Secondary Outcome Measures

Full Information

First Posted
January 9, 2021
Last Updated
January 28, 2021
Sponsor
South Egypt Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04732390
Brief Title
Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy
Official Title
Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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: Vital signs (heart rate, noninvasive blood pressure, and oxygen saturation). 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) 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). Time and amount to request analgesia (PCA patient controlled analgesia morphine (demand dose 1-2 mg, lock out 6-10 min)) at NRS≥3. Side effect of studied drugs as (hypotension, sedation , respiration depression and vomiting ) and complication of the block for 24h post- operative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP(A) (CONTROL GROUP)
Arm Type
Placebo Comparator
Arm Description
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.
Arm Title
Group (M)
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
erector spinae block with bupivacaine
Intervention Description
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5
Intervention Type
Procedure
Intervention Name(s)
erector spinae block with bupivacaine and magnesium sulphate
Intervention Description
Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.
Primary Outcome Measure Information:
Title
analgesia request
Description
first request for analgesia .
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
peter R Edward, MSc
Phone
1224083376
Ext
0020
Email
Peter_rafaat85@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
peter R Edward, MSc
Organizational Affiliation
specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assiut
ZIP/Postal Code
171516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
peter R Edward, MSc
Phone
1224083376
Ext
0020
Email
Peter_rafaat85@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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