Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

Overview

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.

Full Title of Study: “Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2015

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)

Interventions

  • Drug: Levobupivacaine
    • Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine
  • Drug: Levobupivacaine and Tramadol
    • Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol

Arms, Groups and Cohorts

  • Placebo Comparator: Levobupivacaine
    • Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine
  • Active Comparator: Levobupivacaine and Tramadol
    • Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pain
    • Time Frame: For the first 24 hours after surgery
    • Postoperative pain will be assessed by utilizing visual analogue scale (VAS)

Secondary Measures

  • Changes in heart rate
    • Time Frame: For one hour after surgery
  • Changes in blood pressure
    • Time Frame: For one hour after surgery
  • Changes in peripheral oxygen saturation
    • Time Frame: For one hour after surgery
  • Changes in end-tidal carbon dioxide tension
    • Time Frame: For one hour after surgery
  • Time for first analgesic request from extubation
    • Time Frame: for 24 hours after surgery
  • Total analgesics received for 24 hrs after surgery
    • Time Frame: for 24 hours after surgery

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Salwa MS Hayes, MD, Principal Investigator, Assistant Professor of Anesthesia and Surgical Intensive Care
    • Reem A Sharkawy, MD, Study Director, Lecture of Anesthesia and Surgical Intensive Care
    • Tamer EM Farahat, MD, Study Chair, Lecture of Anesthesia and Surgical Intensive Care

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