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Completed

NCT Number: NCT02462577

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Assiut University

Asyut, 171516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local instillation of morphine to surgical wound

Drug

comparison between different drug doses effects on pain

Other names: morphine sulphate

Primary outcomes

  1. changes in acute pain intensity from the baseline

    Time frame: at 2,4,6,12,24,36 and 48 hour postoperatively

    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).

Secondary outcomes

  1. Postoperative adverse effects

    Time frame: 2,4,6,12,24,36 and 48 hour postoperatively.

    nausea, vomiting respiratory depression, itching and sedation

  2. The probability of developing chronic neuropathic pain

    Time frame: after one month and after two months postoperatively

    postoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2015
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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