Efficacy of Tramadol With Levobupivacaine for Modified Pe... | NCT02625506

Studies
Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

NCT02625506

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Sep 11, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Breast Cancer
Radical Mastectomy Surgery

Interventions

Levobupivacaine
Levobupivacaine and Tramadol

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2012Actual

Primary Completion Date

Dec 1, 2015Actual

Completion Date

Jan 1, 2016Actual

First Submitted Date

Nov 21, 2015

First Submission Date that Met QC Criteria

Dec 5, 2015

First Posted Date

Dec 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2020

Last Update Posted Date

Sep 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levobupivacaine	Placebo Comparator	Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine	Drug: Levobupivacaine
Levobupivacaine and Tramadol	Active Comparator	Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol	Drug: Levobupivacaine and Tramadol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levobupivacaine	Drug	Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine	Levobupivacaine

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salwa MS Hayes, MD	Assistant Professor of Anesthesia and Surgical Intensive Care	Principal Investigator
Reem A Sharkawy, MD	Lecture of Anesthesia and Surgical Intensive Care	Study Director
Tamer EM Farahat, MD	Lecture of Anesthesia and Surgical Intensive Care	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University, Mansoura Oncology Center		Al Mansurah	DK	050	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077554	Levobupivacaine
D014147	Tramadol

Ancestor Terms

ID	Term
D002045	Bupivacaine
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided