Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

NCT02625506 | Completed DMC

• 1 other identifier: R/15.05.67
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine in the reduction of postoperative pain, postoperative opioid consumption after modified radical mastectomy surgery.

Conditions

Breast Cancer; Radical Mastectomy Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Postoperative pain will be assessed by utilizing visual analogue scale (VAS)

  For the first 24 hours after surgery

Secondary Outcomes (6)

• Changes in heart rate

  For one hour after surgery

• Changes in blood pressure

  For one hour after surgery

• Changes in peripheral oxygen saturation

  For one hour after surgery

• Changes in end-tidal carbon dioxide tension

  For one hour after surgery

• Time for first analgesic request from extubation

  for 24 hours after surgery

Study Arms (2)

Levobupivacaine

PLACEBO COMPARATOR

Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine

Drug: Levobupivacaine

Levobupivacaine and Tramadol

ACTIVE COMPARATOR

Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol

Drug: Levobupivacaine and Tramadol

Interventions

Levobupivacaine DRUG

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine

Levobupivacaine

Levobupivacaine and Tramadol DRUG

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol

Levobupivacaine and Tramadol

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status I or II.
• Patients scheduled for radical mastectomy surgery.

You may not qualify if:

• Severe or uncompensated cardiovascular diseases
• renal diseases
• Hepatic diseases
• Endocrinal diseases.
• Pregnancy
• Postpartum
• Lactating females
• Allergy to study medications.
• Local skin infection
• Bleeding disorder
• Coagulation abnormality
• Spine deformity
• chest deformity
• Psychiatric disease

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Mansoura Oncology Center

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Levobupivacaine; Tramadol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• Salwa MS Hayes, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

• Reem A Sharkawy, MD

  Lecture of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

• Tamer EM Farahat, MD

  Lecture of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: December 9, 2015
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

EG (1)