Clinical trial NCT02185859: Effect of Perioperative Intravenous Lidocaine Infusion and Magnesium Infusion on the Functional Recovery After General Anesthesia in the Patients Undergoing Breast Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Lidocaine
Magnesium
Mastectomy
Functional Recovery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 126
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Postsurgical pain is a relevant side effect following surgery which increases the risk of various complications and delays postoperative patient recovery. Among the many types of surgeries, mastectomy causes not only acute but also chronic pain in many patients. Therefore, it is important to control pain and increase patients' recovery satisfaction following many kinds of operations by using as small an opioid analgesic dose as possible and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical stimuli. An intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control by reducing postoperative pain and opioid consumption. Another report showed that an intraoperative intravenous injection of lidocaine improved the quality of postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy patient. In addition, a review article on the effect of intraoperative intravenous injection of magnesium found it to be an effective analgesic that may be added to conventional opioid-based therapy because it generally reduces opioid consumption, decreases pain assessment for 24 hours after surgery, and lacks severe side effects in relation to magnesium administration. However, there has been insufficient research comparing the intraoperative intravenous injection of lidocaine or magnesium in terms of which is more helpful for general functional recovery and decreased postoperative pain. Recently, the scope of research on anesthesia has come to embrace postanesthetic recovery; to help patients return to daily life, the research trend is now shifting from the improvement or resolution of a specific symptom to the measurement of general recovery. A widely used method to measure postoperative recovery is the Quality of Recovery 40 (QoR-40) survey.

Therefore, in this study, the researchers investigated the intraoperative intravenous injection of lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in the functional recovery of mastectomy patients after general anesthesia.


Eligibility criteria: Inclusion Criteria:

-Patients aged between 20 and 65 who have undergone mastectomy due to breast cancer and of American Society of Anesthesiologists (ASA) Physical Status Class 1 or Class 2

Exclusion Criteria:

* Patients experiencing pain for any cause or taking an analgesic
* Pregnant patients
* Patients with severe heart, kidney, or liver disease
* Patients with a psychiatric or neurological disorder
* Patients with a contraindication or allergic response to lidocaine
* Patients with a contraindication or allergic response to magnesium

Primary outcomes:
measure: The difference of QoR-40 global scores
timeFrame: 24 hours after mastectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center
Study officials:
References: