Postoperative PainNCT04920669
Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia
A study testing erector spinae block with bupivacaine and erector spinae block with bupivacaine + dexmedetomidine in people with Postoperative Pain, run by Mohamed Elsayed Hassan at 1 site in Egypt.
Trial summary
60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- erector spinae block with bupivacaine and erector spinae block with bupivacaine + dexmedetomidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Sep 2021
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged (18-70) years
- Belongs to American Society of Anaesthesiologists physical status class II.
- Scheduled for breast cancer surgeries.
Who cannot join
- Patient refusal.
- Local infection at the site of the block.
- Cardiac dysfunction (ejection fraction <45%).
- Preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (PCA) device.
- Allergy to one of the study drugs.
- Pregnancy.
- Coagulopathy (PC <60% and platelet count<100.000).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Dexmedetomidine Improve the Analgesic Duration and Efficacy of Erector Spinae Plane Block in Breast Cancer Surgeries?
60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.
Read the detailed description
60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are numerical rating scales and incidence of opioid side effects.
- Conditions
- Postoperative Pain
- Being tested
- erector spinae block with bupivacaine, erector spinae block with bupivacaine + dexmedetomidine
- Keywords
- Erector spinae block., dexmedetomidine., Postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae block with bupivacaineProcedure or surgery
Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%
erector spinae block with bupivacaine + dexmedetomidineProcedure or surgery
Patients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| erector spinae block | Experimental | erector spinae block with 20 ml bupivacaine Receives: Procedure: erector spinae block with bupivacaine |
| erector spinae block + dexmedetomidine | Experimental | erector spinae block with 19 ml bupivacaine + dexmedetomidine Receives: Procedure: erector spinae block with bupivacaine + dexmedetomidine |
| control group | No intervention | standard general anesthesia without any block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first request of analgesia
Time from recovery of anesthesia till first request for analgesia to relive pain.
Measured: The first postoperative day
Secondary outcomes (3)
Total morphine consumption in first postoperative 24 hours
The amount of morphine required to relieve pain will be recorded
Measured: First 24 postoperative hours
Intraoperative fentanyl requirement
The amount of fentanyl required during anesthesia will be recorded
Measured: During anesthesia
Numerical rating scale
Numerical rating scale (from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) will be recorded in different time intervals during the first 24 hours after surgery
Measured: The first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Elsayed Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Elsayed Hassan, National Cancer Institute, Egypt
- Investigators
- Mohamed E Hassan, MD, Principal investigator, National Cancer Institute, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920669
- Sponsor's protocol ID
- AP2014-50103
- Status last verified
- Aug 2021
- First submitted
- 30 May 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Dexmedetomidine Improve the Analgesic Duration and Efficacy of Erector Spinae Plane Block in Breast Cancer Surgeries?
- ClinicalTrials.gov ID
- NCT04920669
- Acronym / sponsor ID
- AP2014-50103
- Conditions
- Postoperative Pain
- Keywords
- Erector spinae block., dexmedetomidine., Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mohamed Elsayed HassanUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- 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.
60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.
Detailed description
60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are numerical rating scales and incidence of opioid side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| erector spinae block | Experimental | Procedure: erector spinae block with bupivacaineerector spinae block with 20 ml bupivacaine |
| erector spinae block + dexmedetomidine | Experimental | Procedure: erector spinae block with bupivacaine + dexmedetomidineerector spinae block with 19 ml bupivacaine + dexmedetomidine |
| control group | No intervention | –standard general anesthesia without any block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged (18-70) years
- Belongs to American Society of Anaesthesiologists physical status class II.
- Scheduled for breast cancer surgeries.
Key exclusion criteria (7 listed)
- Patient refusal.
- Local infection at the site of the block.
- Cardiac dysfunction (ejection fraction <45%).
- Preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (PCA) device.
- Allergy to one of the study drugs.
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 |
|---|---|---|
| erector spinae block with bupivacainePatients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5% | Procedure or surgery | erector spinae block |
| erector spinae block with bupivacaine + dexmedetomidinePatients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine | Procedure or surgery | erector spinae block + dexmedetomidine |
Primary outcome
Time to first request of analgesia
Time frame: The first postoperative day
Time from recovery of anesthesia till first request for analgesia to relive pain.
3 secondary outcomes
Total morphine consumption in first postoperative 24 hours
Time frame: First 24 postoperative hours
Intraoperative fentanyl requirement
Time frame: During anesthesia
Numerical rating scale
Time frame: The first 24 postoperative hours
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 6 Apr 2022.
- 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.
Mohamed E Hassan, MD principal investigator
National Cancer Institute, Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae block with bupivacaine and erector spinae block with bupivacaine + dexmedetomidine in people with Postoperative Pain, run by Mohamed Elsayed Hassan 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 5 inclusion and 7 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 6 Apr 2022. 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.
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?
Time to first request of analgesia (time frame: The first postoperative day). 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 6 Apr 2022.