Acute PainPhase 1/2NCT02935933
Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain
A Phase 1/2 study testing bupivicaine, morphine and Dexmedetomidine in people with Acute Pain and Chronic Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could improve the analgesic effect and thus reduce postoperative morphine consumption and development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients undergoing major breast cancer surgery, i.e., modified… Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Acute Pain, Chronic Pain
- What is being tested?
- bupivicaine, morphine and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Jun 2018
- Phase
- Phase 1/2
- 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physical status classes I to III ( weight 50 - 85 kg), will be scheduled for unilateral modified radical mastectomy (MRM) with axillary evacuation will be consecutively enrolled.
Who cannot join
- patient refusal,
- patients with a known allergy to investigated drugs,
- bleeding disorders,
- anatomical abnormalities,
- infection in the paravertebral region,
- pregnancy, breast feeding,
- a history of drug or alcohol abuse, and patients with chronic pain or regularly receiving analgesics.
- patients subjected for bilateral mastectomy or any unilateral breast surgery other than MRM with axillary evacuation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Pain
Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could improve the analgesic effect and thus reduce postoperative morphine consumption and development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients undergoing major breast cancer surgery, i.e., modified radical mastectomy (MRM) and breast conservation surgery with axillary lymph node dissection.
Read the detailed description
Breast cancer is the most commonly diagnosed malignancy and a leading cause of cancer-related deaths among women. Surgery followed by chemotherapy and/or radiotherapy are the mainstay of current management. Chronic pain, or persistent postsurgical pain, which until recently was considered infrequent after breast cancer surgery (BCS), affects 60% to 80% of breast cancer survivors. The exact cause of chronic pain after BCS is not clear, but there is an association between acute postoperative pain and chronic pain generation after BCS. Postoperative pain intensity and analgesic consumption are significantly higher in patients who develop chronic pain after BCS, and it is suggested that optimizing postoperative pain management may reduce chronic pain. preoperative paravertebral block (PVB) administration in additional to general anesthesia, which has consistently been demonstrated to improve acute postoperative pain control and decrease length of hospital stay. The role of TPVB in preventing chronic pain is still evolving. Karmakar et al. shed more light on the impact of TPVBs in preventing and reducing the severity of chronic pain after breast surgery.
The discovery of peripheral opioid receptors led to the clinical application of adding opioids to local anesthetics for peripheral nerve blocks. Studies from the 1990s showed mixed results from the addition of morphine to peripheral nerve blocks, with two suggesting enhancement of analgesia duration and several showing no benefit at all.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that has been shown to have both sedative and analgesic effects. Although it is approved only for intravenous (IV) sedation, it has been extensively used for off-label indications, including neuraxial and peripheral nerve blocks, with good results. A significant prolongation of duration of analgesia has been reported when dexmedetomidine was added to LA for epidural analgesia, caudal block, subarachnoid block, PVB, brachial plexus block, ulnar nerve block and greater palatine nerve block.
- Conditions
- Acute Pain, Chronic Pain
- Being tested
- bupivicaine, morphine, Dexmedetomidine
- 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.
bupivicaineDrug
Paravertebral block
morphineDrug
DexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block with bupivacaine | Active comparator | patients received 20 ml of bupivacaine 0.25% paravertebrally in 3 levels, divided into 6-7 ml in each level Receives: Drug: bupivicaine |
| Paravertebral block with bupivacaine + morphine | Active comparator | patients received 20 ml of bupivacaine 0.25% +5 mg morphine paravertebrally in 3 levels, divided into 6-7 ml in each level. Receives: Drug: bupivicaine; Drug: morphine |
| Paravertebral block with bupivacaine + dexmedetomidine | Active comparator | patients received 20 ml of bupivacaine 0.25% + 1 μg/kg dexmedetomidine paravertebrally in 3 levels divided into 6-7 ml in each level. Receives: Drug: bupivicaine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total dose of morphine consumption
the total dose of morphine consumption
Measured: 48 hours
Secondary outcomes (2)
visual analouge scale
The pain intensity at rest (VAS-R) and arm movement of 90° (VAS-M) will be evaluated by VAS score at the same point of assessments.
Measured: 0 (immediately after recovery from anesthesia), 2,4,6,12,24,36 and 48 hour postoperatively
chronic postmastectomy pain
The probability of developing chronic neuropathic pain will be assessed during regular postoperative examination in pain clinic in South Egypt Cancer Institute using LANSS ) in the 1st, 2nd and 3rd postoperative months
Measured: 1,2,3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2017
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935933
- Sponsor's protocol ID
- 347
- Status last verified
- Jan 2018
- First submitted
- 12 Oct 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Pain
- ClinicalTrials.gov ID
- NCT02935933
- Acronym / sponsor ID
- 347
- Conditions
- Acute Pain, Chronic Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 18 Oct 2016 (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.
Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could improve the analgesic effect and thus reduce postoperative morphine consumption and development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients undergoing major breast cancer surgery, i.e., modified radical mastectomy (MRM) and breast conservation surgery with axillary lymph node dissection.
Detailed description
Breast cancer is the most commonly diagnosed malignancy and a leading cause of cancer-related deaths among women. Surgery followed by chemotherapy and/or radiotherapy are the mainstay of current management. Chronic pain, or persistent postsurgical pain, which until recently was considered infrequent after breast cancer surgery (BCS), affects 60% to 80% of breast cancer survivors. The exact cause of chronic pain after BCS is not clear, but there is an association between acute postoperative pain and chronic pain generation after BCS. Postoperative pain intensity and analgesic consumption are significantly higher in patients who develop chronic pain after BCS, and it is suggested that optimizing postoperative pain management may reduce chronic pain. preoperative paravertebral block (PVB) administration in additional to general anesthesia, which has consistently been demonstrated to improve acute postoperative pain control and decrease length of hospital stay. The role of TPVB in preventing chronic pain is still evolving. Karmakar et al. shed more light on the impact of TPVBs in preventing and reducing the severity of chronic pain after breast surgery.
The discovery of peripheral opioid receptors led to the clinical application of adding opioids to local anesthetics for peripheral nerve blocks. Studies from the 1990s showed mixed results from the addition of morphine to peripheral nerve blocks, with two suggesting enhancement of analgesia duration and several showing no benefit at all.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that has been shown to have both sedative and analgesic effects. Although it is approved only for intravenous (IV) sedation, it has been extensively used for off-label indications, including neuraxial and peripheral nerve blocks, with good results. A significant prolongation of duration of analgesia has been reported when dexmedetomidine was added to LA for epidural analgesia, caudal block, subarachnoid block, PVB, brachial plexus block, ulnar nerve block and greater palatine nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block with bupivacaine | Active comparator | Drug: bupivicainepatients received 20 ml of bupivacaine 0.25% paravertebrally in 3 levels, divided into 6-7 ml in each level |
| Paravertebral block with bupivacaine + morphine | Active comparator | Drug: bupivicaine, Drug: morphinepatients received 20 ml of bupivacaine 0.25% +5 mg morphine paravertebrally in 3 levels, divided into 6-7 ml in each level. |
| Paravertebral block with bupivacaine + dexmedetomidine | Active comparator | Drug: bupivicaine, Drug: Dexmedetomidinepatients received 20 ml of bupivacaine 0.25% + 1 μg/kg dexmedetomidine paravertebrally in 3 levels divided into 6-7 ml in each level. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- physical status classes I to III ( weight 50 - 85 kg), will be scheduled for unilateral modified radical mastectomy (MRM) with axillary evacuation will be consecutively enrolled.
Key exclusion criteria (8 listed)
- patient refusal,
- patients with a known allergy to investigated drugs,
- bleeding disorders,
- anatomical abnormalities,
- infection in the paravertebral region,
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 |
|---|---|---|
| bupivicaineParavertebral block | Drug | Paravertebral block with bupivacaine, Paravertebral block with bupivacaine + dexmedetomidine, Paravertebral block with bupivacaine + morphine |
| morphine | Drug | Paravertebral block with bupivacaine + morphine |
| Dexmedetomidine | Drug | Paravertebral block with bupivacaine + dexmedetomidine |
Primary outcome
total dose of morphine consumption
Time frame: 48 hours
the total dose of morphine consumption
2 secondary outcomes
visual analouge scale
Time frame: 0 (immediately after recovery from anesthesia), 2,4,6,12,24,36 and 48 hour postoperatively
chronic postmastectomy pain
Time frame: 1,2,3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bupivicaine, morphine and Dexmedetomidine 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 8 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: status not confirmed, as of the sponsor's last update on 12 Jan 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
total dose of morphine consumption (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2018.