Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block
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|ClinicalTrials.gov Identifier: NCT02625506|
Recruitment Status : Unknown
Verified December 2015 by Mansoura University.
Recruitment status was: Enrolling by invitation
First Posted : December 9, 2015
Last Update Posted : December 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Radical Mastectomy Surgery||Drug: Levobupivacaine Drug: Levobupivacaine and Tramadol||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||January 2016|
Placebo Comparator: Levobupivacaine
Patients will be subjected for radical mastectomy surgery and pectoral nerve block with 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
- Postoperative pain [ Time Frame: For the first 24 hours after surgery ]Postoperative pain will be assessed by utilizing visual analogue scale (VAS)
- Changes in heart rate [ Time Frame: For one hour after surgery ]
- Changes in blood pressure [ Time Frame: For one hour after surgery ]
- Changes in peripheral oxygen saturation [ Time Frame: For one hour after surgery ]
- Changes in end-tidal carbon dioxide tension [ Time Frame: For one hour after surgery ]
- Time for first analgesic request from extubation [ Time Frame: for 24 hours after surgery ]
- Total analgesics received for 24 hrs after surgery [ Time Frame: for 24 hours after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625506
|Mansoura University, Mansoura Oncology Center|
|Mansoura, DK, Egypt, 050|
|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|