Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625506
• Other study ID #: R/15.05.67
• Status: Completed
• Phase: N/A
• Start date: June 1, 2012
• Est. completion date: January 1, 2016

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2016
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Radical Mastectomy Surgery

Intervention

Drug:
• Levobupivacaine
Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine
• Levobupivacaine and Tramadol
Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol

Locations

Country	Name	City	State
Egypt	Mansoura University, Mansoura Oncology Center	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain will be assessed by utilizing visual analogue scale (VAS)	For the first 24 hours after surgery
Secondary	Changes in heart rate		For one hour after surgery
Secondary	Changes in blood pressure		For one hour after surgery
Secondary	Changes in peripheral oxygen saturation		For one hour after surgery
Secondary	Changes in end-tidal carbon dioxide tension		For one hour after surgery
Secondary	Time for first analgesic request from extubation		for 24 hours after surgery
Secondary	Total analgesics received for 24 hrs after surgery		for 24 hours after surgery