Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Assiut, Egypten, 171516
- Assiut University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: local instillation of morphine 5 mg
5 ml plain bupivacaine 0.5% and 5 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
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comparison between different drug doses effects on pain
Andra namn:
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|
Aktiv komparator: local instillation of morphine 10 mg
5 ml plain bupivacaine 0.5% and 10 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
|
comparison between different drug doses effects on pain
Andra namn:
|
|
Aktiv komparator: local instillation of morphine 15 mg
5 ml plain bupivacaine 0.5% and 15 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
|
comparison between different drug doses effects on pain
Andra namn:
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Placebo-jämförare: local instillation of local anesthetics
5 ml plain bupivacaine 0.5% .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
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comparison between different drug doses effects on pain
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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changes in acute pain intensity from the baseline
Tidsram: at 2,4,6,12,24,36 and 48 hour postoperatively
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Visual 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).
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at 2,4,6,12,24,36 and 48 hour postoperatively
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative adverse effects
Tidsram: 2,4,6,12,24,36 and 48 hour postoperatively.
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nausea, vomiting respiratory depression, itching and sedation
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2,4,6,12,24,36 and 48 hour postoperatively.
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The probability of developing chronic neuropathic pain
Tidsram: after one month and after two months postoperatively
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postoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale
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after one month and after two months postoperatively
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Shereen M Mohamed, MD, Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 209
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