Breast Cancer Clinical Trial
Verified date | October 2015 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference of QoR-40 global scores | The investigators will evaluate the quality of recovery after general anesthesia by considering the global score (200 points in total) of QoR-40 surveys, which is obtained by summing the subtotal scores for emotional status, physical comfort, psychological support, physical independence, and pain. The QoR-40 administered 24 hours after the operation is the primary endpoint of this research. | 24 hours after mastectomy | No |
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