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Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy

Primary Purpose

Pain, Postoperative

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy

ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy

ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Erector Spinae Block, magnesium sulphate, dexmedetomidine

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleAccepts 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 Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group (C) (control group):

Group (D) (Dexmetonidine group):

Group (M) (magnesium slphate group):

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 + 1μ/kg dexmedetomidine 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 requirement

first request for analgesia and total analgesia requirements

Secondary Outcome Measures

chronic pain assessment

Assessment of chronic pain at 1-3 and 6 month post-operatively using LANSS pain score. a score of 12 or more is suggestive of neuropathic pain.

Full Information

NCT ID

NCT04732364

First Posted

January 6, 2021

Last Updated

January 28, 2021

Sponsor

South Egypt Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04732364

Brief Title

Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy

Official Title

Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 30, 2018 (Actual)

Primary Completion Date

February 28, 2021 (Anticipated)

Study Completion Date

February 28, 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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

3 groups. Group (C) / (I):20 patient (control group) : Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5. Group (D)/ (II) :20 patient (Dexmetonidine group) : Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine. Group (M) / (III) : 20 patient (magnesium slphate group) : Patient will receive 20ml 0.25% levobupivacaineas 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.

6. Conditions and Keywords

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

Pain, Postoperative

Keywords

Erector Spinae Block, magnesium sulphate, dexmedetomidine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group (C) (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 (D) (Dexmetonidine group):

Arm Type

Active Comparator

Arm Description

Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5..

Arm Title

Group (M) (magnesium slphate group):

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)

ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy

Intervention Description

Primary Outcome Measure Information:

Title

analgesia requirement

Description

first request for analgesia and total analgesia requirements

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

chronic pain assessment

Description

Assessment of chronic pain at 1-3 and 6 month post-operatively using LANSS pain score. a score of 12 or more is suggestive of neuropathic pain.

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

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

12. IPD Sharing Statement

Learn more about this trial

Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy

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