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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04732364
• Other study ID #: peter SECI
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: April 30, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2021
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesia requirement	first request for analgesia and total analgesia requirements	24 hours
Secondary	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.	6 months