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

Primary Purpose

Acute Pain, Chronic Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
local instillation of morphine to surgical wound
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Local morphine, Postmastectomy pain

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

local instillation of morphine 5 mg

local instillation of morphine 10 mg

local instillation of morphine 15 mg

local instillation of local anesthetics

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

changes in acute pain intensity from the baseline
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 Outcome Measures

Postoperative adverse effects
nausea, vomiting respiratory depression, itching and sedation
The probability of developing chronic neuropathic pain
postoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale

Full Information

First Posted
May 28, 2015
Last Updated
December 29, 2015
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02462577
Brief Title
Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain
Official Title
Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Chronic Pain
Keywords
Local morphine, Postmastectomy pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
local instillation of morphine 5 mg
Arm Type
Active Comparator
Arm 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.
Arm Title
local instillation of morphine 10 mg
Arm Type
Active Comparator
Arm 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.
Arm Title
local instillation of morphine 15 mg
Arm Type
Active Comparator
Arm 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.
Arm Title
local instillation of local anesthetics
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
local instillation of morphine to surgical wound
Other Intervention Name(s)
morphine sulphate
Intervention Description
comparison between different drug doses effects on pain
Primary Outcome Measure Information:
Title
changes in acute pain intensity from the baseline
Description
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).
Time Frame
at 2,4,6,12,24,36 and 48 hour postoperatively
Secondary Outcome Measure Information:
Title
Postoperative adverse effects
Description
nausea, vomiting respiratory depression, itching and sedation
Time Frame
2,4,6,12,24,36 and 48 hour postoperatively.
Title
The probability of developing chronic neuropathic pain
Description
postoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale
Time Frame
after one month and after two months postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen M Mohamed, MD
Organizational Affiliation
Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
171516
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
27755490
Citation
Mohamed SA, Abdel-Ghaffar HS, Kamal SM, Fares KM, Hamza HM. Effect of Topical Morphine on Acute and Chronic Postmastectomy Pain: What Is the Optimum Dose? Reg Anesth Pain Med. 2016 Nov/Dec;41(6):704-710. doi: 10.1097/AAP.0000000000000496.
Results Reference
derived

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

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