Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT02625506

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Radical Mastectomy Surgery	Drug: Levobupivacaine Drug: Levobupivacaine and Tramadol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University, Mansoura Oncology Center	Mansoura	DK	Egypt	050

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT02625506

Other Study ID Numbers:

R/15.05.67

First Posted:

Dec 9, 2015

Last Update Posted:

Sep 11, 2020

Last Verified:

Sep 1, 2020

Additional relevant MeSH terms:

Tramadol

Levobupivacaine

Study Results

No Results Posted as of Sep 11, 2020