Acute PainPhase 2NCT02462577
Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain
A Phase 2 study testing local instillation of morphine to surgical wound in people with Acute Pain and Chronic Pain, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Acute Pain, Chronic Pain
- What is being tested?
- local instillation of morphine to surgical wound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Pain, Chronic Pain
- Being tested
- local instillation of morphine to surgical wound
- Keywords
- Local morphine, Postmastectomy pain
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local instillation of morphine to surgical woundDrug
Also called morphine sulphate
comparison between different drug doses effects on pain
| Study group | Role | What they receive |
|---|---|---|
| local instillation of morphine 5 mg | Active comparator | 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. Receives: Drug: local instillation of morphine to surgical wound |
| local instillation of morphine 10 mg | Active comparator | 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. Receives: Drug: local instillation of morphine to surgical wound |
| local instillation of morphine 15 mg | Active comparator | 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. Receives: Drug: local instillation of morphine to surgical wound |
| local instillation of local anesthetics | Placebo comparator | 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. Receives: Drug: local instillation of morphine to surgical wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 2,4,6,12,24,36 and 48 hour postoperatively
Secondary outcomes (2)
Postoperative adverse effects
nausea, vomiting respiratory depression, itching and sedation
Measured: 2,4,6,12,24,36 and 48 hour postoperatively.
The probability of developing chronic neuropathic pain
postoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale
Measured: after one month and after two months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
- Investigators
- Shereen M Mohamed, MD, Principal investigator, Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462577
- Sponsor's protocol ID
- 209
- Status last verified
- Dec 2015
- First submitted
- 28 May 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27755490
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain
- ClinicalTrials.gov ID
- NCT02462577
- Acronym / sponsor ID
- 209
- Conditions
- Acute Pain, Chronic Pain
- Keywords
- Local morphine, Postmastectomy pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| local instillation of morphine 5 mg | Active comparator | Drug: local instillation of morphine to surgical wound5 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. |
| local instillation of morphine 10 mg | Active comparator | Drug: local instillation of morphine to surgical wound5 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. |
| local instillation of morphine 15 mg | Active comparator | Drug: local instillation of morphine to surgical wound5 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. |
| local instillation of local anesthetics | Placebo comparator | Drug: local instillation of morphine to surgical wound5 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local instillation of morphine to surgical woundAlso: morphine sulphatecomparison between different drug doses effects on pain | Drug | local instillation of local anesthetics, local instillation of morphine 10 mg, local instillation of morphine 15 mg, local instillation of morphine 5 mg |
Primary outcome
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).
2 secondary outcomes
Postoperative adverse effects
Time frame: 2,4,6,12,24,36 and 48 hour postoperatively.
The probability of developing chronic neuropathic pain
Time frame: after one month and after two months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Derived from this study: PubMed 27755490Mohamed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shereen M Mohamed, MD principal investigator
Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing local instillation of morphine to surgical wound in people with Acute Pain and Chronic Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in acute pain intensity from the baseline (time frame: at 2,4,6,12,24,36 and 48 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.