Clinical trial NCT02625506: Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block
Official title: Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Radical Mastectomy Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: Postoperative pain
timeFrame: For the first 24 hours after surgery
Secondary outcomes:
measure: Changes in heart rate
timeFrame: For one hour after surgery
measure: Changes in blood pressure
timeFrame: For one hour after surgery
measure: Changes in peripheral oxygen saturation
timeFrame: For one hour after surgery
measure: Changes in end-tidal carbon dioxide tension
timeFrame: For one hour after surgery
measure: Time for first analgesic request from extubation
timeFrame: for 24 hours after surgery
measure: Total analgesics received for 24 hrs after surgery
timeFrame: for 24 hours after surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University, Mansoura Oncology Center
state: DK
Study officials:
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Salwa MS Hayes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecture of Anesthesia and Surgical Intensive Care
name: Reem A Sharkawy, MD
role: STUDY_DIRECTOR
affiliation: Lecture of Anesthesia and Surgical Intensive Care
name: Tamer EM Farahat, MD
role: STUDY_CHAIR
References: