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Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

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ClinicalTrials.gov Identifier: NCT02625506
Recruitment Status : Unknown
Verified December 2015 by Mansoura University.
Recruitment status was:  Enrolling by invitation
First Posted : December 9, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radical Mastectomy Surgery Drug: Levobupivacaine Drug: Levobupivacaine and Tramadol Not Applicable

Detailed Description:

Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief, however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax.

Pecs block is less invasive procedure involving ultrasound guided inter-fascial injections which has been suggested as potential alternative analgesic technique.

The block produces excellent analgesia and can be used as a rescue block in cases where the analgesia provided by the paravertebral or epidural was patchy or ineffective .

Different drugs, including opioids, non-steroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to local anesthetics to improve the duration and quality of analgesia.Tramadol has also been used for pain management of patients.

The power of this clinical trial was prospectively calculated using the G Power analysis program. Using a priory power analysis with accuracy mode calculations with visual analogue score (VAS) as the primary variant and assuming type I error protection of 0.05 and an effect size convention of 0.9, a total sample size of 54 patients (27 patients in each group) produced a power of 0.90. To protect against drop out cases we added 6 cases to the total number (total of 60 cases)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery
Study Start Date : June 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
Drug Information available for: Tramadol

Arm Intervention/treatment
Placebo Comparator: Levobupivacaine
Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine
Drug: Levobupivacaine
Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine

Active Comparator: Levobupivacaine and Tramadol
Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol
Drug: Levobupivacaine and Tramadol
Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: For the first 24 hours after surgery ]
    Postoperative pain will be assessed by utilizing visual analogue scale (VAS)


Secondary Outcome Measures :
  1. Changes in heart rate [ Time Frame: For one hour after surgery ]
  2. Changes in blood pressure [ Time Frame: For one hour after surgery ]
  3. Changes in peripheral oxygen saturation [ Time Frame: For one hour after surgery ]
  4. Changes in end-tidal carbon dioxide tension [ Time Frame: For one hour after surgery ]
  5. Time for first analgesic request from extubation [ Time Frame: for 24 hours after surgery ]
  6. Total analgesics received for 24 hrs after surgery [ Time Frame: for 24 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625506


Locations
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Egypt
Mansoura University, Mansoura Oncology Center
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Salwa MS Hayes, MD Assistant Professor of Anesthesia and Surgical Intensive Care
Study Director: Reem A Sharkawy, MD Lecture of Anesthesia and Surgical Intensive Care
Study Chair: Tamer EM Farahat, MD Lecture of Anesthesia and Surgical Intensive Care

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT02625506     History of Changes
Other Study ID Numbers: R/15.05.67
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Tramadol
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics