PainPhase 4NCT00913003
Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
A Phase 4 study testing Lidocaine in people with Pain, run by Northwestern University.
Trial summary
The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Oct 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- Gender: Female
- ASA Physical Status I-III
- Non-pregnant
- Surgery: Unilateral total or segmental mastectomy
- Language: English speaking
- Consent: Obtained
Who cannot join
- Age: Under 18 or over 65 years
- ASA Physical Status >III
- Pregnancy
- Language: Non-English speaking
- Allergy to Lidocaine or amide local anesthetics
- Contraindication to succinylcholine
Show all 13Show fewer
- History and/or EKG evidence of conduction defect
- Renal failure (Creatinine >1.7 mg/dL)
- Patient expected to remain intubated after procedure
- Chronic home opioid or steroid use
- Opioid use within one week prior to procedure
- Drug or alcohol abuse
- Inability to use PCA
About this study
The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome.
This study will have 2 groups. Participants will be randomized into one of each group. The first group will be administered the drug lidocaine prior to surgery and the second group Group B will be administered saline (salt water). This is a blinded study which means the participant will not know which group they have been assigned. The subjects participation will last 12 months (surveys post operatively).
Read the detailed description
Patients will be recruited up to 21 days prior to the day of surgery. The consent form will be reviewed with the patient, and the patient will be allowed to take a copy home. If the patient does not have an EKG within the past 6 weeks in her medical record, an EKG will be obtained at the time of recruitment. At the time of recruitment, the patient will be randomized using a computer-generated code. Group A will receive lidocaine during surgery, and Group B will receive saline (placebo) during surgery.The study drug will be prepared by the investigator(s). The anesthesiologist and research nurse will be blinded. If necessary in the event of an emergency, these individuals may be unblinded.
Group A (Lidocaine):
Induction: 1.5 mg/kg IV (IBW) bolus, administered prior to Propofol. The maximum loading dose administered will not exceed 150 mg IV Infusion: 33.3 mcg/kg/min IV (IBW), initiated before surgical incision.Discontinue infusion 1 hour after skin closure complete.No other local anesthetics administered intra-operatively
Group B (Saline):
Induction: IV bolus, administered prior to Propofol Infusion: Initiate before surgical incision (rate calculated as if for lidocaine infusion). Discontinue infusion 1 hour after skin closure complete No local anesthetics administered intra-operatively. Baseline thermal quantitative sensory testing (QST) scores will be obtained pre-operatively using TSA-II Neuro Sensory Analyzer (Medoc Advanced Medical Systems, Durham, NC).
Baseline Modified Quality of Recovery (MQoR-40) Survey will be obtained on the morning of surgery.
Preoperative anxiety, depression, and pain characterization will be measured within 24 hours of the time of surgery using a validated questionnaire (Hospital Anxiety and Depression Scale). If the questionnaire responses indicate the patient is experiencing depressive symptoms, the patient will be notified of the results and instructed to follow up with her primary care physician.
Intraoperatively, patients will receive a standardized anesthetic (management protocol attached).
Two blood samples for lidocaine levels will be obtained on subjects. The first lidocaine blood sample will be collected after the lidocaine/placebo bolus in the operating room. The second lidocaine blood sample will be obtained when the lidocaine/placebo infusion has been discontinued (one hour after skin closure). A total of 5 mLs of blood will be obtained.
Patients will be examined daily by a research nurse while admitted to the hospital. Daily pain scores will be noted, as will complications related to the perioperative period. If the subject is discharged within 24 hours the research nurse will call by phone to ask the subject about pain 0-10 and type and amount of pain relievers used since discharge.MQoR-40 will be administered on the day of discharge. It will be repeated at 6 weeks, 6 months, and 12 months after surgery. Patients will complete the Mastectomy Patient Follow-Up, Modified LANNS Pain Scale, and McGill Pain questionnaires at 6 months and 12 months after surgery for detection of Post-Mastectomy Pain Syndrome (PMPS).
The definition of PMPS will be: The presence of a dull, burning,and aching sensation in the anterior chest, arm, and axilla exacerbated by movement of the shoulder girdle.
Appendix 1-Anesthetic Management Protocol Appendix 2-HADS Appendix 3-MQoR-40 Appendix 4-Modified LANNS and McGill Appendix 5-Follow-Up Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Group A
Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)
PlaceboDrug
Also called Group B
Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Group B using saline as a placebo. Receives: Drug: Placebo |
| Lidocaine | Active comparator | Group A lidocaine infusion and bolus. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Hydromorphone
Total IV hydromorphone administered during surgery to 24 hours post surgery
Measured: 24 hour
Secondary outcomes (2)
Number of Participants Experiencing Post Operative Nausea
Nausea at any time during the post operative period for 48 hours
Measured: Immediate post operative to 48 hours
Number of Participants Experiencing Post Operative Ileus
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: PI terminated employment with the University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Altman, Northwestern University
- Investigators
- Christian Altman, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913003
- Sponsor's protocol ID
- STU0008753
- Status last verified
- Feb 2015
- First submitted
- 2 Jun 2009
- Last updated
- 4 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
PubMed 9459225Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
PubMed 15763418Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
PubMed 17197840Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
PubMed 15041597Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.
PubMed 15655557McCleane G. Intravenous lidocaine: an outdated or underutilized treatment for pain? J Palliat Med. 2007 Jun;10(3):798-805. doi: 10.1089/jpm.2006.0209.
PubMed 17592992Owczuk R, Wujtewicz MA, Sawicka W, Piankowski A, Polak-Krzeminska A, Morzuch E, Wujtewicz M. The effect of intravenous lidocaine on QT changes during tracheal intubation. Anaesthesia. 2008 Sep;63(9):924-31. doi: 10.1111/j.1365-2044.2008.05525.x. Epub 2008 Jun 10.
PubMed 18547294Violet JA, Dearling JL, Green AJ, Begent RH, Pedley RB. Fractionated 131I anti-CEA radioimmunotherapy: effects on xenograft tumour growth and haematological toxicity in mice. Br J Cancer. 2008 Aug 19;99(4):632-8. doi: 10.1038/sj.bjc.6604511.
PubMed 18682714Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.
PubMed 17457830
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT00913003
- Acronym / sponsor ID
- STU0008753
- Conditions
- Pain
- Keywords
- Lidocaine, Mastectomy, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI terminated employment with the University
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 4 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome.
This study will have 2 groups. Participants will be randomized into one of each group. The first group will be administered the drug lidocaine prior to surgery and the second group Group B will be administered saline (salt water). This is a blinded study which means the participant will not know which group they have been assigned. The subjects participation will last 12 months (surveys post operatively).
Detailed description
Patients will be recruited up to 21 days prior to the day of surgery. The consent form will be reviewed with the patient, and the patient will be allowed to take a copy home. If the patient does not have an EKG within the past 6 weeks in her medical record, an EKG will be obtained at the time of recruitment. At the time of recruitment, the patient will be randomized using a computer-generated code. Group A will receive lidocaine during surgery, and Group B will receive saline (placebo) during surgery.The study drug will be prepared by the investigator(s). The anesthesiologist and research nurse will be blinded. If necessary in the event of an emergency, these individuals may be unblinded.
Group A (Lidocaine):
Induction: 1.5 mg/kg IV (IBW) bolus, administered prior to Propofol. The maximum loading dose administered will not exceed 150 mg IV Infusion: 33.3 mcg/kg/min IV (IBW), initiated before surgical incision.Discontinue infusion 1 hour after skin closure complete.No other local anesthetics administered intra-operatively
Group B (Saline):
Induction: IV bolus, administered prior to Propofol Infusion: Initiate before surgical incision (rate calculated as if for lidocaine infusion). Discontinue infusion 1 hour after skin closure complete No local anesthetics administered intra-operatively. Baseline thermal quantitative sensory testing (QST) scores will be obtained pre-operatively using TSA-II Neuro Sensory Analyzer (Medoc Advanced Medical Systems, Durham, NC).
Baseline Modified Quality of Recovery (MQoR-40) Survey will be obtained on the morning of surgery.
Preoperative anxiety, depression, and pain characterization will be measured within 24 hours of the time of surgery using a validated questionnaire (Hospital Anxiety and Depression Scale). If the questionnaire responses indicate the patient is experiencing depressive symptoms, the patient will be notified of the results and instructed to follow up with her primary care physician.
Intraoperatively, patients will receive a standardized anesthetic (management protocol attached).
Two blood samples for lidocaine levels will be obtained on subjects. The first lidocaine blood sample will be collected after the lidocaine/placebo bolus in the operating room. The second lidocaine blood sample will be obtained when the lidocaine/placebo infusion has been discontinued (one hour after skin closure). A total of 5 mLs of blood will be obtained.
Patients will be examined daily by a research nurse while admitted to the hospital. Daily pain scores will be noted, as will complications related to the perioperative period. If the subject is discharged within 24 hours the research nurse will call by phone to ask the subject about pain 0-10 and type and amount of pain relievers used since discharge.MQoR-40 will be administered on the day of discharge. It will be repeated at 6 weeks, 6 months, and 12 months after surgery. Patients will complete the Mastectomy Patient Follow-Up, Modified LANNS Pain Scale, and McGill Pain questionnaires at 6 months and 12 months after surgery for detection of Post-Mastectomy Pain Syndrome (PMPS).
The definition of PMPS will be: The presence of a dull, burning,and aching sensation in the anterior chest, arm, and axilla exacerbated by movement of the shoulder girdle.
Appendix 1-Anesthetic Management Protocol Appendix 2-HADS Appendix 3-MQoR-40 Appendix 4-Modified LANNS and McGill Appendix 5-Follow-Up Questionnaire
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboGroup B using saline as a placebo. |
| Lidocaine | Active comparator | Drug: LidocaineGroup A lidocaine infusion and bolus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18-65 years
- Gender: Female
- ASA Physical Status I-III
- Non-pregnant
- Surgery: Unilateral total or segmental mastectomy
Key exclusion criteria (13 listed)
- Age: Under 18 or over 65 years
- ASA Physical Status >III
- Pregnancy
- Language: Non-English speaking
- Allergy to Lidocaine or amide local anesthetics
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: Group ALidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW) | Drug | Lidocaine |
| PlaceboAlso: Group BPlacebo (normal saline) bolus similar to the lidocaine infusion minus active drug | Drug | Placebo |
Primary outcome
24 Hour Hydromorphone
Time frame: 24 hour
Total IV hydromorphone administered during surgery to 24 hours post surgery
2 secondary outcomes
Number of Participants Experiencing Post Operative Nausea
Time frame: Immediate post operative to 48 hours
Number of Participants Experiencing Post Operative Ileus
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9459225Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
- Background: PubMed 15763418Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
- Background: PubMed 17197840Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
- Background: PubMed 15041597Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
- Background: PubMed 15655557Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.
- Background: PubMed 17592992McCleane G. Intravenous lidocaine: an outdated or underutilized treatment for pain? J Palliat Med. 2007 Jun;10(3):798-805. doi: 10.1089/jpm.2006.0209.
- Background: PubMed 18547294Owczuk R, Wujtewicz MA, Sawicka W, Piankowski A, Polak-Krzeminska A, Morzuch E, Wujtewicz M. The effect of intravenous lidocaine on QT changes during tracheal intubation. Anaesthesia. 2008 Sep;63(9):924-31. doi: 10.1111/j.1365-2044.2008.05525.x. Epub 2008 Jun 10.
- Background: PubMed 18682714Violet JA, Dearling JL, Green AJ, Begent RH, Pedley RB. Fractionated 131I anti-CEA radioimmunotherapy: effects on xenograft tumour growth and haematological toxicity in mice. Br J Cancer. 2008 Aug 19;99(4):632-8. doi: 10.1038/sj.bjc.6604511.
- Background: PubMed 17457830Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.
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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.
Christian Altman, M.D. principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Pain, run by Northwestern University.
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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
24 Hour Hydromorphone (time frame: 24 hour). 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 NCT00913003, which also lists 9 linked publications.
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 4 Feb 2015.