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Three-level Injection Paravertebral Block vs General Anesthesia in Mastectomy

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ClinicalTrials.gov Identifier: NCT02065947
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Petchara Sundarathiti MD, Ramathibodi Hospital

Brief Summary:

The purpose of the study is to investigate if paravertebral block for breast surgery may improve postoperative analgesia and shorten length of hospital stay. Within a prospective clinical trial sixty women (ASA I - III) undergoing unilateral mastectomy surgery with axillary dissection are enrolled. Exclusion criteria are general infection and local infection at the site of planned puncture, anatomic deformities of the thoracic spine, coagulation disorders, allergy against local anesthetics or contrast agents, pregnancy or breast-feeding and BMI ≥ 30 kg/m2.

Patients are randomly assigned to two groups, 30 patients each, by using block of four method. Group I patients receive paravertebral block at spine level Th 4 via catheter; Group II patients will have general anesthesia without nitrous oxide.

Paravertebral block (PVB) will be entirely performed by one person (1st author) with the patient in prone position. In randomly selected patients the catheter localization will be detected by fluoroscopy after injection of 0.5 ml contrast agent. The catheter positioned at about 8 cm from skin level, a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000 will be injected sequentially 10 ml each while withdrawing the catheter 2 cm after the first and again 2 cm after the second injection. Then the catheter will be removed. Low dose intraoperative sedation is provided with IV midazolam 2-3 mg, ketamine 0.5 mg/kg bolus and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1 - 1.5 mcg/mL to allow spontaneous breathing. In case surgical approach is not tolerated, the regional block is graded insufficient, and it is switched to general anesthesia.

At postoperative care unit (PACU) the pain score using visual rating scale (VRS) from 0 to 10 (worst imaginable pain) is assessed at rest and on movement of the shoulder every 15 minutes until 60 minutes. Analgesia is provided by IV morphine 0.04 mg/kg boluses with a 15-min dosing interval to maintain VRS - score < 3. Time to first analgesic demand and 24-hr analgesics consumption is recorded as well as postoperative nausea and vomiting (PONV). Complications are recorded including those related to the paravertebral block, such as Horner's syndrome, epidural spreading, hypotension that is not related to another. Patients will be checked 6, 12, and 24hr postoperatively for adverse effects, pain scores, and satisfaction scores.


Condition or disease Intervention/treatment Phase
Radical Mastectomy Procedure: paravertebral block Drug: fentanyl, propofol, atracurium Drug: lidocaine , adrenaline, ketamine bolus, midazolam Device: catheter with 3-level-injection Drug: sevoflurane and 50% oxygen in air Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Three-level Injection Paravertebral Block Using Paravertebral Catheter Compared to General Anesthesia in Mastectomy Surgery
Study Start Date : October 2013
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Active Comparator: general anesthesia
fentanyl 0,05 - 0.1 mg/h, propofol 150 - 200 mg, atracurium
Drug: fentanyl, propofol, atracurium
endotracheal intubation

Drug: sevoflurane and 50% oxygen in air
Experimental: paravertebral block
a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000, ketamine bolus 0.5 mg/kg, midazolam 2-3 mg and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1-1.5 mcg/mL
Procedure: paravertebral block
catheter with 3-level-injection
Other Name: 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000, ketamine bolus 0.5 mg/kg, midazolam 2-3 mg and TCI propofol at Ce of 1-1.5 mcg/ml

Drug: lidocaine , adrenaline, ketamine bolus, midazolam
a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000, ketamine bolus 0.5 mg/kg, midazolam 2-3 mg and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1-1.5 mcg/mL

Device: catheter with 3-level-injection



Primary Outcome Measures :
  1. postoperative analgesia requirement (opioids + nonsteroidal antiinflammatory drug) [ Time Frame: 6 months (October 2013 - March 2014) ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Samples are collected after patients' written informed consent in accordance with the Declaration of Helsinki and institutional research board approval. Sixty women (ASA I - III) undergoing unilateral mastectomy surgery with axillary dissection (radical lymph node removal or sentinel node biopsy) are enrolled. Exclusion criteria are general infection and local infection at the site of planned puncture, anatomic deformities of the thoracic spine, coagulation disorders, allergy against local anesthetics or contrast agents, such as Iopamiro 300, pregnancy or breast-feeding and BMI ≥ 30 kg/m2.

Exclusion Criteria:

  • Patients who did not meet the inclusion criteria.

Information from the National Library of Medicine

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): NCT02065947


Locations
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Thailand
Faculty of Medicine Ramathibodi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Investigators
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Study Chair: Benno von Bormann, MD Mahidol University Bangkok
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Petchara Sundarathiti MD, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT02065947    
Other Study ID Numbers: MURA 09-56-23
3-LEVEL-PVB ( Other Identifier: MURA 09-56-23 )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Keywords provided by Prof. Petchara Sundarathiti MD, Ramathibodi Hospital:
paravertebral block, mastectomy, efficiency
Additional relevant MeSH terms:
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Lidocaine
Epinephrine
Racepinephrine
Fentanyl
Midazolam
Ketamine
Bupivacaine
Propofol
Sevoflurane
Epinephryl borate
Atracurium
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents