Postoperative PainEDPARMRCTNCT05110339
Efficacy of Dexmedetomidine on Postoperative Analgesia
A study testing Ropivacaine plus dexmedetomidine and Ropivacaine in people with Postoperative Pain, run by Universidad Autónoma de Tamaulipas at 1 site in Mexico.
Trial summary
This prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine plus dexmedetomidine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2019to 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing radical mastectomy for pathology "breast cancer"
- Patient undergoing anesthetic technique due to erector spinae plane block
- Informed consent to perform the anesthesia technique.
- Karnofsky> 80 points
Who cannot join
- Emergency surgery
- Patient with mental pathology that prevents pain assessment.
- Rejection of anesthetic technique.
- Patient with allergy to local anesthetics
- Patient with local infection of the puncture site for application of the erector spinae block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dexmedetomidine on Postoperative Analgesia After Radical Mastectomy: Randomized Controlled Trial
This prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. The investigators hypothesis is that the administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the plane in the erector spinae is less effective in controlling acute postoperative pain in radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.
Read the detailed description
Patients undergoing radical mastectomy are randomly assigned to receive, in addition to standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine at 0.3 mcg kg (n = 15) for the intervention group. General anesthesia was induced using anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular relaxation with cisatracurium at a dose of 0.1 mg / kg.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine plus dexmedetomidine, Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine plus dexmedetomidineDrug
Erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg.
RopivacaineDrug
Erector spinae block with ropivacaine at a dose of 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine plus Dexmedetomidine | Experimental | In addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg corrected in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet. Receives: Drug: Ropivacaine plus dexmedetomidine |
| Control group | Active comparator | In addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Measured: 0 hours
Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Measured: 6 hours
Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Measured: 12 hours
Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Measured: 24 hours
Secondary outcomes (2)
Additional opioid-type drugs
The presence of additional opioid analgesic requirements will be evaluated. All patients will be prescribed intravenous analgesia on a strict schedule as follows: ketorolac 30mg in intravenous infusion every 8 hours.
If the follow-up assessment of postoperative pain is greater than or equal to 4 in the VAS, additional medication is indicated, which is considered as analgesic rescue and which consists of buprenorphine at a dose of 2 mcg kg corrected with 30% according to ideal weight intravenously in both groups, with a dose no greater than 6 mcg / kg / day.
Measured: 24 hours
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Nov 2019
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized double-blinded study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Tamaulipas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110339
- Sponsor's protocol ID
- HCAECV01
- Acronym
- EDPARMRCT
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine on Postoperative Analgesia After Radical Mastectomy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05110339
- Acronym / sponsor ID
- EDPARMRCT / HCAECV01
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Autónoma de TamaulipasUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Nov 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.
This prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. The investigators hypothesis is that the administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the plane in the erector spinae is less effective in controlling acute postoperative pain in radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.
Detailed description
Patients undergoing radical mastectomy are randomly assigned to receive, in addition to standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine at 0.3 mcg kg (n = 15) for the intervention group. General anesthesia was induced using anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular relaxation with cisatracurium at a dose of 0.1 mg / kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine plus Dexmedetomidine | Experimental | Drug: Ropivacaine plus dexmedetomidineIn addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg corrected in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet. |
| Control group | Active comparator | Drug: RopivacaineIn addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing radical mastectomy for pathology "breast cancer"
- Patient undergoing anesthetic technique due to erector spinae plane block
- Informed consent to perform the anesthesia technique.
- Karnofsky> 80 points
Key exclusion criteria (5 listed)
- Emergency surgery
- Patient with mental pathology that prevents pain assessment.
- Rejection of anesthetic technique.
- Patient with allergy to local anesthetics
- Patient with local infection of the puncture site for application of the erector spinae block
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 |
|---|---|---|
| Ropivacaine plus dexmedetomidineErector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg. | Drug | Ropivacaine plus Dexmedetomidine |
| RopivacaineErector spinae block with ropivacaine at a dose of 0.5%. | Drug | Control group |
Primary outcome
Postoperative Pain score
Time frame: 0 hours
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Postoperative Pain score
Time frame: 6 hours
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Postoperative Pain score
Time frame: 12 hours
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Postoperative Pain score
Time frame: 24 hours
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
2 secondary outcomes
Additional opioid-type drugs
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 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 5 Nov 2021.
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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 study testing Ropivacaine plus dexmedetomidine and Ropivacaine in people with Postoperative Pain, run by Universidad Autónoma de Tamaulipas at 1 site in Mexico.
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 4 inclusion and 5 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 5 Nov 2021. 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 Mexico. 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?
Postoperative Pain score (time frame: 0 hours). The study lists 4 primary outcomes in all. 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 5 Nov 2021.