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Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain

Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02462577
Enrollment
120
Registered
2015-06-04
Start date
2015-01-31
Completion date
2015-12-31
Last updated
2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Chronic Pain

Keywords

Local morphine, Postmastectomy pain

Brief summary

This study investigate the effect of addition morphine to locally instillation bupivacaine on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

Detailed description

Breast cancer is one of the most common cancer diagnoses in women and a significant cause of mortality and morbidity worldwide.Surgical treatment indicated in most patients. Persistent pain and sensory disturbances following surgery is a significant clinical problem with an average prevalence of 20-23.9%. Post-mastectomy chronic pain syndrome (PMPS) is defined as pain of neuropathic character located in the area of surgery and/or the ipsilateral arm, present at least 4 days per week, and with an average intensity of at least 3 on a numeric rating scale from 0 to 10. The pathological mechanisms may be related to patient characteristics, surgical technique and adjuvant therapy. Although the genesis of pain is multi-factorial, sectioning of the intercostobrachial nerve (a cutaneous branch of T1-2) is the nerve lesion diagnosed most often. Uncontrolled acute postoperative pain is defined as an important risk factor for the development of chronic pain. Local anesthetics have been investigated in cancer breast patients through many routes; paravertebral blocks, thoracic epidurals, wound infiltration, topical lidocaine patch, and the topical application of EMLA( Eutectic Mixture of Local Anesthetics) cream on operation site. Most of above studies suggested a better outcome in terms of reduced postoperative pain and improved patient satisfaction. Opioids exert a local analgesic effect is based on several observations: • Nociceptive afferent nerve fibers contain peripheral opioid receptors which are silent except in the presence of local inflammation. • Morphine and its metabolites are largely undetectable systemically when applied topically to skin ulcers, suggesting the analgesic effect is local • Peripheral opioid injections for local analgesia, such as intra-articular morphine after knee surgery, have been found to be effective in several trials. An effective topical opioid analgesic that could be applied to inflamed or open skin lesions would be a useful option for some patients where other options for pain relief have been exhausted.

Interventions

DRUGlocal instillation of morphine to surgical wound

comparison between different drug doses effects on pain

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection

Exclusion criteria

* allergy to the study drugs * significant cardiac, respiratory, renal or hepatic disease * drug or alcohol abuse * psychiatric illness that would interfere with perception and assessment of pain

Design outcomes

Primary

MeasureTime frameDescription
changes in acute pain intensity from the baselineat 2,4,6,12,24,36 and 48 hour postoperativelyVisual analogue pain scale score at rest (VAS-R) and during movement or ipsilateral arm abduction (VAS-M), will be assessed at the same points score ranging from 0 to 10 (zero = no pain and 10 = the worst pain imaginable).

Secondary

MeasureTime frameDescription
Postoperative adverse effects2,4,6,12,24,36 and 48 hour postoperatively.nausea, vomiting respiratory depression, itching and sedation
The probability of developing chronic neuropathic painafter one month and after two months postoperativelypostoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026