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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Chronic Pain; Acute Pain

Treatments: Drug: local instillation of morphine to surgical wound

Study type: Interventional

Funder types: Other

Identifiers

NCT02462577

209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

local instillation of morphine 5 mg

Active Comparator group

Description:

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.

Treatment:

Drug: local instillation of morphine to surgical wound

local instillation of morphine 10 mg

Active Comparator group

Description:

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.

Treatment:

Drug: local instillation of morphine to surgical wound

local instillation of morphine 15 mg

Active Comparator group

Description:

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.

Treatment:

Drug: local instillation of morphine to surgical wound

local instillation of local anesthetics

Placebo Comparator group

Description:

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.

Treatment:

Drug: local instillation of morphine to surgical wound