Cancer, BreastPhase 1NCT03502395
Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion
A Phase 1 study testing Lidocaine and Normal saline in people with Cancer, Breast, run by Assiut University at 1 site in Egypt.
Trial summary
A prospective, double blinded and randomized study included women with breast cancer and underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group and control group. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cancer, Breast
- What is being tested?
- Lidocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2017to 13 Feb 2018
- Phase
- Phase 1
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, American society of Anesthesiologist I or II
Who cannot join
- Patients with contralateral breast cancer, metastatic tumor, morbid obesity (BMI> 40), allergy to an amide local anesthetic, or morphine sulphate, heart block, renal, or liver dysfunction, or substance abuse disorder, or chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion and Its Relation to Post-mastectomy Pain: a Prospective Double Blinded Study
A prospective, double blinded and randomized study included women with breast cancer and underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group and control group.
Read the detailed description
Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, ASA I or II were included in the study.
- Group I (lidocaine): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
- Group II (control):- A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
- Conditions
- Cancer, Breast
- Being tested
- Lidocaine, Normal saline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Active group
): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
Normal salineDrug
Also called Placebo group
A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure). Receives: Drug: Lidocaine |
| Group II | Placebo comparator | A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Opiorphin level
Measuring the opiorphin blood level
Measured: 24 hours postoperative
Secondary outcomes (1)
Visual analog pain score
Measure pain intensity. Graded from 0=no pain to 10=worst pain
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start4 Apr 2017
- Primary completion21 Jan 2018
- Study completion13 Feb 2018
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 Cancer, BreastStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Abdelrady S Ibrahim, M.D., Principal investigator, Assiut University faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502395
- Sponsor's protocol ID
- IRB0000871246
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rougeot C, Robert F, Menz L, Bisson JF, Messaoudi M. Systemically active human opiorphin is a potent yet non-addictive analgesic without drug tolerance effects. J Physiol Pharmacol. 2010 Aug;61(4):483-90.
PubMed 20814077
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion and Its Relation to Post-mastectomy Pain: a Prospective Double Blinded Study
- ClinicalTrials.gov ID
- NCT03502395
- Acronym / sponsor ID
- IRB0000871246
- Conditions
- Cancer, Breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 21 Jan 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 18 Apr 2018 (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.
A prospective, double blinded and randomized study included women with breast cancer and underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group and control group.
Detailed description
Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, ASA I or II were included in the study.
- Group I (lidocaine): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
- Group II (control):- A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: LidocainePatients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure). |
| Group II | Placebo comparator | Drug: Normal salineA standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, American society of Anesthesiologist I or II
Key exclusion criteria (1 listed)
- Patients with contralateral breast cancer, metastatic tumor, morbid obesity (BMI> 40), allergy to an amide local anesthetic, or morphine sulphate, heart block, renal, or liver dysfunction, or substance abuse disorder, or chronic opioid use
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 |
|---|---|---|
| LidocaineAlso: Active group): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure). | Drug | Group I |
| Normal salineAlso: Placebo groupA standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion. | Drug | Group II |
Primary outcome
Serum Opiorphin level
Time frame: 24 hours postoperative
Measuring the opiorphin blood level
1 secondary outcome
Visual analog pain score
Time frame: 24 hours postoperative
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 19 Apr 2018.
- Results publication: PubMed 20814077Rougeot C, Robert F, Menz L, Bisson JF, Messaoudi M. Systemically active human opiorphin is a potent yet non-addictive analgesic without drug tolerance effects. J Physiol Pharmacol. 2010 Aug;61(4):483-90.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer, Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Abdelrady S Ibrahim, M.D. principal investigator
Assiut University faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine and Normal saline in people with Cancer, Breast, 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 1 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 19 Apr 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. 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 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.
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?
Serum Opiorphin level (time frame: 24 hours postoperative). 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 NCT03502395, 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 19 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.