Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Radical Mastectomy Surgery
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Levobupivacaine and Tramadol

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University, Mansoura Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Salwa MS Hayes, MD, assistant professor of Anesthesia and Surgical Intensive Care; Study Director: Reem A Sharkawy, MD, Lecture of Anesthesia and Surgical Intensive Care; Study Chair: Tamer EM Farahat, MD, Lecture of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 21, 2015
• First Submitted That Met QC Criteria: December 5, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Tramadol; Levobupivacaine
• Other Study ID Numbers: R/15.05.67