Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

Not Applicable

Completed

• Conditions: Radical Mastectomy Surgery; Breast Cancer
• Interventions: Drug: Levobupivacaine and Tramadol; Drug: Levobupivacaine

• Registration Number: NCT02625506
• Lead Sponsor: 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.

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)

Study Timeline

• Study Start: 2012-06-01
• Study First Submitted: 2015-11-21
• Primary Completion: 2015-12-01
• Study First Submitted QC: 2015-12-05
• Study First Posted: 2015-12-09
• Study Completion: 2016-01-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine and Tramadol	Levobupivacaine and Tramadol	Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol
Levobupivacaine	Levobupivacaine	Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total analgesics received for 24 hrs after surgery	for 24 hours after surgery
Time for first analgesic request from extubation	for 24 hours after surgery
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

Trial Locations

Locations (1)

Mansoura University, Mansoura Oncology Center; 🇪🇬 Mansoura, DK, Egypt