Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

NCT ID: NCT02625506

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2016-01-01

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)

Conditions

Breast Cancer; Radical Mastectomy Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Levobupivacaine

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

Group Type: PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine

Levobupivacaine and Tramadol

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

Group Type: ACTIVE_COMPARATOR

Levobupivacaine and Tramadol

Intervention Type: DRUG

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol

Interventions

Levobupivacaine

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine

Intervention Type: DRUG

Levobupivacaine and Tramadol

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salwa MS Hayes, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Anesthesia and Surgical Intensive Care

Reem A Sharkawy, MD

Role: STUDY_DIRECTOR

Lecture of Anesthesia and Surgical Intensive Care

Tamer EM Farahat, MD

Role: STUDY_CHAIR

Lecture of Anesthesia and Surgical Intensive Care

Locations

Mansoura University, Mansoura Oncology Center

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

R/15.05.67

Identifier Type: -

Identifier Source: org_study_id