Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery

Conditions
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Breast Cancer, Radical Mastectomy Surgery

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Levobupivacaine and Tramadol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Levobupivacaine<br>Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine | Drug: Levobupivacaine<br>* Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine<br>|
| Active Comparator: Levobupivacaine and Tramadol<br>Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol | Drug: Levobupivacaine and Tramadol<br>* Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be assessed by utilizing visual analogue scale (VAS) | For the first 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total analgesics received for 24 hrs after surgery |  | for 24 hours after surgery |