Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03660020
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.5
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Local anesthetic; Drug: Hyaluronidase	N/A

Detailed Description

two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Hyalorounidase on the Spread of Local Anaesthetics in Erector Spinae Plane Block
• Actual Study Start Date: May 19, 2018
• Anticipated Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: local anaesthetic group	Drug: Local anesthetic; ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only
Active Comparator: hyalorounidase group	Drug: Hyaluronidase; hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy

Outcome Measures

Primary Outcome Measures

1. degree of local anaesthetics spread after injection in both group [10 minutes after block]

   spread of local anaesthics will be examined under floroscopic guide

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female

2. ASA I, II, III

3. Elective surgery

Exclusion Criteria:

1. Patient refusal

2. Infection at injection site

3. Allergy to the given drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

• Study Chair: saeid elsawy, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rasha Hamed, clinical professor, Assiut University
• ClinicalTrials.gov Identifier: NCT03660020
• Other Study ID Numbers: NBBL
• First Posted: Sep 6, 2018
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of Apr 9, 2020