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

Sponsor

South Egypt Cancer Institute (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04732364

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 30, 2018

Anticipated Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group (C) (control group): Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.	Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy 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
Active Comparator: Group (D) (Dexmetonidine group): Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5..	Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy 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
Active Comparator: Group (M) (magnesium slphate group): Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5..	Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy 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

Arm

Intervention/Treatment

Placebo Comparator: Group (C) (control group):

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

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

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

Active Comparator: Group (D) (Dexmetonidine group):

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

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

Active Comparator: Group (M) (magnesium slphate group):

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

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

Outcome Measures

Primary Outcome Measures

analgesia requirement [24 hours]
first request for analgesia and total analgesia requirements

Secondary Outcome Measures

chronic pain assessment [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Egypt Cancer Institute	Assiut		Egypt	171516

Sponsors and Collaborators

South Egypt Cancer Institute

Investigators

Principal Investigator: peter R Edward, MSc, specialist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Rafaat Edward Iskander, principal investigator, South Egypt Cancer Institute

ClinicalTrials.gov Identifier:

NCT04732364

Other Study ID Numbers:

peter SECI

First Posted:

Feb 1, 2021

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Rafaat Edward Iskander, principal investigator, South Egypt Cancer Institute

Erector Spinae Block

magnesium sulphate

dexmedetomidine

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Feb 1, 2021