Pecs II Block as Alternative for Paravertebral Block in Modified Radical Mastectomy

NCT02839083 | Unknown DMC

• 1 other identifier: MD ∕ 153
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Breast surgeries are usually associated with significant postoperative pain. Suitability of analgesic technique after breast surgery is always questionable. The aim of this study is to compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance as regards to potential complications and analgesic efficacy of both techniques in the first 24 h after modified radical mastectomy.

Conditions

Modified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Pain visual analog scale is used to assess the severity of postoperative pain

  For 24 hours after surgery

Secondary Outcomes (2)

• Duration of postoperative analgesia

  for 12 hours after surgery

• Cumulative postoperative meperidine consumption

  for 48 hours after surgery

Study Arms (2)

Thoracic Paravertebral group

PLACEBO COMPARATOR

Ultrasound guided thoracic paravertebral block

Other: Thoracic Paravertebral group

Pecs II group

ACTIVE COMPARATOR

Ultrasound guided Pecs II block

Other: Pecs II group

Interventions

Thoracic Paravertebral group OTHER

Thoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml

Thoracic Paravertebral group

Pecs II group OTHER

Ultrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml

Pecs II group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Association for Anesthesiologists physical status I or II
• Body mass index \> 40 kg/m2

You may not qualify if:

• Patient refusal
• Severe or uncompensated cardiovascular disease.
• Significant renal disease.
• Significant hepatic disease.
• Significant endocrinal disease.
• Pregnancy.
• Postpartum period.
• Lactating females.
• Allergy to any of the study medication.
• Coagulation disorders.
• Infection at the site of needle insertion.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, DK, 050, Egypt

Location

Study Officials

• Abd-Elaziz Metawa, MD

  Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2016
• First Posted: July 20, 2016
• Study Start: April 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

EG (1)