The impact of administering lidocaine intravenously prior to removing the breathing tube on recovery following breast surgery
| ISRCTN | ISRCTN71855856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71855856 |
| Secondary identifying numbers | 1280-07 |
- Submission date
- 02/07/2023
- Registration date
- 04/07/2023
- Last edited
- 04/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aim
Breast surgery is a common procedure with potential postoperative complications such as pain, nausea, and delayed recovery. By exploring the use of IV lidocaine during surgery, we can potentially alleviate these issues and enhance the overall recovery experience.
Lidocaine is commonly used as a local anesthetic, however, its benefits in the context of general anesthesia and postoperative recovery are still being studied. Focusing on women undergoing breast surgery allows us to specifically evaluate the effects of IV lidocaine in this patient population.
Understanding the impact of IV lidocaine on emergence, early recovery, and late recovery after breast surgery can lead to improved patient outcomes and satisfaction. Positive results from the study may encourage healthcare providers to incorporate lidocaine administration into anesthesia protocols for breast surgery, potentially reducing postoperative pain, shortening recovery times, and enhancing overall patient well-being.
We aimed to investigate whether IV lidocaine improves emergence, early, and late recovery after general anesthesia in women who undergo breast surgery.
Who can participate?
Sixty-seven women with American Society of Anesthesiologists physical status I-II, scheduled for breast surgery
What does the study involve?
All patients received standardized general anesthesia and were randomized to receive IV lidocaine 1.5 mg/kg bolus (n=34) or saline placebo (n=33) before tracheal extubation.
What are the possible benefits and risks of participating?
IV lidocaine is routinely used at the beginning of anesthesia with minimal complications therefore risks were minimal. The benefit was to participate in the study to enhance medical knowledge.
Where is the study run from?
Opća Bolnica Zadar (Croatia)
When is the study starting and how long is it expected to run for?
April 2007 to December 2013
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Tatjana Simurina, tatjana.simurina@zd.htnet.hr
Contact information
Principal Investigator
Ul. Bože Peričića 5
Zadar
23000
Croatia
 ORCID ID |
0000-0002-2657-5537 |
|---|---|
| Phone | +385 23 505 505 |
| tatjana.simurina@zd.htnet.hr |
Study information
| Study design | Single-center prospective double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effects of intravenous lidocaine bolus before tracheal extubation on recovery after breast surgery – Lidocaine At The End (LATE) study: a randomized controlled clinical trial |
| Study acronym | LATE study |
| Study objectives | We investigated whether IV lidocaine would improve emergence and prevent complications in early and late recovery after general anesthesia in women undergoing breast surgery. |
| Ethics approval(s) |
Approved 24/05/2007, Ethics Committee, General Hospital Zadar (Boze Pericica 5, Zadar, 23000, Croatia; +385 23505505; opca-bolnica-zadar@zd.t-com.hr), ref: 01-1280/07 |
| Health condition(s) or problem(s) studied | Quality of the emergence after general anesthesia, prevention of bucking, cough, sore throat, and PONV for 24 hours after general anesthesia in women who underwent breast surgery |
| Intervention | Patients were randomized by computer-generated random numbers to receive either lidocaine or the same volume of saline (control) on the emergence from anesthesia. At the end of skin closure, volatile anesthetic and N2O were switched off, neostigmine 2.5 mg and atropine 1 mg for neuromuscular blockade reversal were given, and the fresh gas inflow rate was increased to 7 L/min of 100% oxygen. At that time, patients received 2% lidocaine IV (1.5 mg/kg) or the same amount of saline (placebo). No physical stimulations were applied during the emergence. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lidocaine 2% (intravenous) |
| Primary outcome measure | Quality of the emergence measured by: 1. The number of bucking episodes before extubation 2. The number of coughs and sore throat episodes at one, three, and five minutes after extubation, 3. The number of coughs and sore throat episodes at two and 24 hours postoperatively |
| Secondary outcome measures | 1. PONV - postoperative nausea and vomiting (retching) (incidence, number of episodes) 2. Severity of nausea evaluated with a 100-mm visual analog scale (VAS) (0=no pain to 100=maximum pain) at 2 h and 24h postoperatively 3. Postoperative pain evaluated with a 100-mm visual analog scale (VAS) at the same time points (0=no pain to 100=maximum pain) |
| Overall study start date | 01/04/2007 |
| Completion date | 18/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target number of participants | 73 |
| Total final enrolment | 73 |
| Key inclusion criteria | 1. Adult women 2. American Society of Anesthesiologists physical status I to II 3. Women undergoing breast tumor surgery (lumpectomy, simple mastectomy, radical or modified radical mastectomy) |
| Key exclusion criteria | 1. Anticipated difficult intubation 2. Multiple intubation attempts 3. History of sore throat, cough, and respiratory infections 4. Having been intubated within the last two months 5. Chronic obstructive lung disease 6. Asthma 7. Treatment with ß-blocking agents 8. Known hypersensitivity to drugs used in the study protocol 9. Obesity (body mass index >30 kg/m²) 10. The study protocol was broken 11. Conditions that arose that influenced outcomes during the surgery ( unexpected intraoperative drug allergy, severe intraoperative hypotension lasting more than three minutes, perioperative hypoxia lasting more than one minute, excessive blood loss, difficult intubation, or serious postoperative surgical complications) |
| Date of first enrolment | 18/07/2007 |
| Date of final enrolment | 04/12/2013 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Zadar
23000
Croatia
Sponsor information
Hospital/treatment centre
Ul. Bože Peričića 5
Zadar
23000
Croatia
| Phone | +385 23 505 505 |
|---|---|
| opca-bolnica-zadar@zd.t-com.hr | |
| Website | http://www.bolnica-zadar.hr/ |
"ROR" |
https://ror.org/05ds5vg25 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sets generated and analyzed during the study will be available upon request from Dr. Tatjana Šimurina <tatjana.simurina@gmail.com> |
Editorial Notes
04/07/2023: Trial's existence confirmed by Institutional Ethics Committee, General Hospital Zadar
