Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain
Primary Purpose
Acute Pain, Chronic Pain
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
bupivicaine
morphine
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- physical status classes I to III ( weight 50 - 85 kg), will be scheduled for unilateral modified radical mastectomy (MRM) with axillary evacuation will be consecutively enrolled.
Exclusion Criteria:
- patient refusal,
- patients with a known allergy to investigated drugs,
- bleeding disorders,
- anatomical abnormalities,
- infection in the paravertebral region,
- pregnancy, breast feeding,
- a history of drug or alcohol abuse, and patients with chronic pain or regularly receiving analgesics.
- patients subjected for bilateral mastectomy or any unilateral breast surgery other than MRM with axillary evacuation.
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Paravertebral block with bupivacaine
Paravertebral block with bupivacaine + morphine
Paravertebral block with bupivacaine + dexmedetomidine
Arm Description
patients received 20 ml of bupivacaine 0.25% paravertebrally in 3 levels, divided into 6-7 ml in each level
patients received 20 ml of bupivacaine 0.25% +5 mg morphine paravertebrally in 3 levels, divided into 6-7 ml in each level.
patients received 20 ml of bupivacaine 0.25% + 1 μg/kg dexmedetomidine paravertebrally in 3 levels divided into 6-7 ml in each level.
Outcomes
Primary Outcome Measures
total dose of morphine consumption
the total dose of morphine consumption
Secondary Outcome Measures
visual analouge scale
The pain intensity at rest (VAS-R) and arm movement of 90° (VAS-M) will be evaluated by VAS score at the same point of assessments.
chronic postmastectomy pain
The probability of developing chronic neuropathic pain will be assessed during regular postoperative examination in pain clinic in South Egypt Cancer Institute using LANSS ) in the 1st, 2nd and 3rd postoperative months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02935933
Brief Title
Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain
Official Title
Safety and Efficacy of Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could improve the analgesic effect and thus reduce postoperative morphine consumption and development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients undergoing major breast cancer surgery, i.e., modified radical mastectomy (MRM) and breast conservation surgery with axillary lymph node dissection.
Detailed Description
Breast cancer is the most commonly diagnosed malignancy and a leading cause of cancer-related deaths among women. Surgery followed by chemotherapy and/or radiotherapy are the mainstay of current management. Chronic pain, or persistent postsurgical pain, which until recently was considered infrequent after breast cancer surgery (BCS), affects 60% to 80% of breast cancer survivors. The exact cause of chronic pain after BCS is not clear, but there is an association between acute postoperative pain and chronic pain generation after BCS. Postoperative pain intensity and analgesic consumption are significantly higher in patients who develop chronic pain after BCS, and it is suggested that optimizing postoperative pain management may reduce chronic pain. preoperative paravertebral block (PVB) administration in additional to general anesthesia, which has consistently been demonstrated to improve acute postoperative pain control and decrease length of hospital stay. The role of TPVB in preventing chronic pain is still evolving. Karmakar et al. shed more light on the impact of TPVBs in preventing and reducing the severity of chronic pain after breast surgery.
The discovery of peripheral opioid receptors led to the clinical application of adding opioids to local anesthetics for peripheral nerve blocks. Studies from the 1990s showed mixed results from the addition of morphine to peripheral nerve blocks, with two suggesting enhancement of analgesia duration and several showing no benefit at all.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that has been shown to have both sedative and analgesic effects. Although it is approved only for intravenous (IV) sedation, it has been extensively used for off-label indications, including neuraxial and peripheral nerve blocks, with good results. A significant prolongation of duration of analgesia has been reported when dexmedetomidine was added to LA for epidural analgesia, caudal block, subarachnoid block, PVB, brachial plexus block, ulnar nerve block and greater palatine nerve block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paravertebral block with bupivacaine
Arm Type
Active Comparator
Arm Description
patients received 20 ml of bupivacaine 0.25% paravertebrally in 3 levels, divided into 6-7 ml in each level
Arm Title
Paravertebral block with bupivacaine + morphine
Arm Type
Active Comparator
Arm Description
patients received 20 ml of bupivacaine 0.25% +5 mg morphine paravertebrally in 3 levels, divided into 6-7 ml in each level.
Arm Title
Paravertebral block with bupivacaine + dexmedetomidine
Arm Type
Active Comparator
Arm Description
patients received 20 ml of bupivacaine 0.25% + 1 μg/kg dexmedetomidine paravertebrally in 3 levels divided into 6-7 ml in each level.
Intervention Type
Drug
Intervention Name(s)
bupivicaine
Intervention Description
Paravertebral block
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Primary Outcome Measure Information:
Title
total dose of morphine consumption
Description
the total dose of morphine consumption
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
visual analouge scale
Description
The pain intensity at rest (VAS-R) and arm movement of 90° (VAS-M) will be evaluated by VAS score at the same point of assessments.
Time Frame
0 (immediately after recovery from anesthesia), 2,4,6,12,24,36 and 48 hour postoperatively
Title
chronic postmastectomy pain
Description
The probability of developing chronic neuropathic pain will be assessed during regular postoperative examination in pain clinic in South Egypt Cancer Institute using LANSS ) in the 1st, 2nd and 3rd postoperative months
Time Frame
1,2,3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
physical status classes I to III ( weight 50 - 85 kg), will be scheduled for unilateral modified radical mastectomy (MRM) with axillary evacuation will be consecutively enrolled.
Exclusion Criteria:
patient refusal,
patients with a known allergy to investigated drugs,
bleeding disorders,
anatomical abnormalities,
infection in the paravertebral region,
pregnancy, breast feeding,
a history of drug or alcohol abuse, and patients with chronic pain or regularly receiving analgesics.
patients subjected for bilateral mastectomy or any unilateral breast surgery other than MRM with axillary evacuation.
Facility Information:
Facility Name
Assiut University
City
Assiut
State/Province
Iorg0006563
ZIP/Postal Code
171516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain
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