Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

Mansoura University

Status: Completed

Conditions: Breast Cancer; Radical Mastectomy Surgery

Treatments: Drug: Levobupivacaine and Tramadol; Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02625506

R/15.05.67

Details and patient eligibility

About

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 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)

Enrollment: 60 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Levobupivacaine

Placebo Comparator group

Description:

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

Treatment:

Drug: Levobupivacaine

Levobupivacaine and Tramadol

Active Comparator group

Description:

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

Treatment:

Drug: Levobupivacaine and Tramadol