Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain

Safety and Efficacy of Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Pain

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Acute Pain
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: morphine; Drug: bupivicaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Iorg0006563
    • Assiut, Iorg0006563, Egypt, 171516
      • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paravertebral block with bupivacaine; patients received 20 ml of bupivacaine 0.25% paravertebrally in 3 levels, divided into 6-7 ml in each level	Drug: bupivicaine; Paravertebral block
Active Comparator: Paravertebral block with bupivacaine + morphine; patients received 20 ml of bupivacaine 0.25% +5 mg morphine paravertebrally in 3 levels, divided into 6-7 ml in each level.	Drug: morphine; Drug: bupivicaine; Paravertebral block
Active Comparator: Paravertebral block with bupivacaine + dexmedetomidine; patients received 20 ml of bupivacaine 0.25% + 1 μg/kg dexmedetomidine paravertebrally in 3 levels divided into 6-7 ml in each level.	Drug: Dexmedetomidine; Drug: bupivicaine; Paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total dose of morphine consumption	the total dose of morphine consumption	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 (immediately after recovery from anesthesia), 2,4,6,12,24,36 and 48 hour postoperatively
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	1,2,3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine; Morphine
• Other Study ID Numbers: 347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO