Nerve BlockNCT02741232
Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery
A study testing Lidocaine 1% with epinephrine 1/400000 in people with Nerve Block and Mastectomy, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Nerve Block, Mastectomy
- What is being tested?
- Lidocaine 1% with epinephrine 1/400000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to 15 Sep 2017
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 to 3 inclusively
- breast cancer surgery with or without axillary dissection
Who cannot join
- any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia)
- refusal to participate in the study
- patient with dementia
- preoperative breast pain
- preoperative opioid consumption
- breast reconstructive surgery
- bilateral surgery
- pregnant patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial
In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the pectoral block. Our hypothesis is that the pectoral nerve block reduces the opioid consumption during the surgery.
Read the detailed description
After induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). Both groups will receive the same perioperative and postoperative anesthetic protocol. The investigator in charge of the patient will leave the operative room right before the completion of the pectoral block (or the sham block) to preserve randomisation and the block will be performed by another investigator. The pectoral block is performed under ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution between the pectoralis minor muscle and the serratus anterior muscle at the third rib. Anesthesia will be maintained with sevoflurane for a bispectral (BIS) index between 45 and 60. Analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean arterial blood pressure (MAP) in the range of ± 10% of the basal MAP (mean of the last three MAPs obtained before surgical incision, under sevoflurane-only anesthesia). The total remifentanil consumption will be assessed and compared between the groups. The investigators believe that the pectoral nerve block will significantly reduce the intraoperative remifentanil consumption.
- Conditions
- Nerve Block, Mastectomy
- Being tested
- Lidocaine 1% with epinephrine 1/400000, sham block
- Keywords
- analgesics, opioids, pectoral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1% with epinephrine 1/400000Drug
Also called xylocaine with epinephrine
sham blockOther
| Study group | Role | What they receive |
|---|---|---|
| Pectoral nerve block | Active comparator | After induction of general anesthesia and under ultrasound visual guidance, pectoral block is performed with 30 mL total of local anesthetic (1% lidocaine + 1/400000 epinephrine). 10 mL of local anesthetic between pectoralis major muscle and pectoralis minor muscle and 20 mL between pectoralis minor muscle and serratus anterior muscle at the third rib. Receives: Drug: Lidocaine 1% with epinephrine 1/400000 |
| Sham block | Sham comparator | No needle or injection will be used Receives: Other: sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption for the first 30 minutes of surgery
Measured: 30 minutes
Secondary outcomes (6)
Total intraoperative remifentanil consumption
Measured: 2 hours
Total intraoperative sevoflurane consumption
Measured: 2 hours
Postoperative pain evaluation
using the numerical rating scale
Measured: 30 minutes
Postoperative nausea and vomiting evaluation
Measured: 30 minutes
Total time in the recovery room
Measured: 60 minutes
Postoperative opioid consumption
dilaudid consumption
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion30 Aug 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Verdonck, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741232
- Sponsor's protocol ID
- 15075
- Status last verified
- Mar 2019
- First submitted
- 13 Apr 2016
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02741232
- Acronym / sponsor ID
- 15075
- Conditions
- Nerve Block, Mastectomy
- Keywords
- analgesics, opioids, pectoral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 18 Apr 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.
In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the pectoral block. Our hypothesis is that the pectoral nerve block reduces the opioid consumption during the surgery.
Detailed description
After induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). Both groups will receive the same perioperative and postoperative anesthetic protocol. The investigator in charge of the patient will leave the operative room right before the completion of the pectoral block (or the sham block) to preserve randomisation and the block will be performed by another investigator. The pectoral block is performed under ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution between the pectoralis minor muscle and the serratus anterior muscle at the third rib. Anesthesia will be maintained with sevoflurane for a bispectral (BIS) index between 45 and 60. Analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean arterial blood pressure (MAP) in the range of ± 10% of the basal MAP (mean of the last three MAPs obtained before surgical incision, under sevoflurane-only anesthesia). The total remifentanil consumption will be assessed and compared between the groups. The investigators believe that the pectoral nerve block will significantly reduce the intraoperative remifentanil consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectoral nerve block | Active comparator | Drug: Lidocaine 1% with epinephrine 1/400000After induction of general anesthesia and under ultrasound visual guidance, pectoral block is performed with 30 mL total of local anesthetic (1% lidocaine + 1/400000 epinephrine). 10 mL of local anesthetic between pectoralis major muscle and pectoralis minor muscle and 20 mL between pectoralis minor muscle and serratus anterior muscle at the third rib. |
| Sham block | Sham comparator | Other: sham blockNo needle or injection will be used |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1 to 3 inclusively
- breast cancer surgery with or without axillary dissection
Key exclusion criteria (8 listed)
- any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia)
- refusal to participate in the study
- patient with dementia
- preoperative breast pain
- preoperative opioid consumption
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 |
|---|---|---|
| Lidocaine 1% with epinephrine 1/400000Also: xylocaine with epinephrine | Drug | Pectoral nerve block |
| sham block | Other | Sham block |
Primary outcome
Intraoperative remifentanil consumption for the first 30 minutes of surgery
Time frame: 30 minutes
6 secondary outcomes
Total intraoperative remifentanil consumption
Time frame: 2 hours
Total intraoperative sevoflurane consumption
Time frame: 2 hours
Postoperative pain evaluation
Time frame: 30 minutes
Postoperative nausea and vomiting evaluation
Time frame: 30 minutes
Total time in the recovery room
Time frame: 60 minutes
Postoperative opioid consumption
Time frame: 1 hour
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 20 Mar 2019.
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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 Lidocaine 1% with epinephrine 1/400000 in people with Nerve Block and Mastectomy, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 2 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: finished, as of the sponsor's last update on 20 Mar 2019. 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 Canada. 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.
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?
Intraoperative remifentanil consumption for the first 30 minutes of surgery (time frame: 30 minutes). 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 20 Mar 2019.