Hernia, Inguinal Clinical Trial
Official title:
Effect of Bilateral Rectus Sheath Block on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery :A Prospective, Double-Blind, Randomized, Clinical Trial
Postoperative delirium is a common complication in clinical surgery. It has been reported that it can increase postoperative morbidity and mortality and lead to decreased functional and cognitive abilities. The aim of this study was to investigate the effect of ultrasound-guided bilateral rectus sheath blocks (RSB) on postoperative delirium in elderly patients undergoing laparoendoscopic single-site surgery (LESS) A double-blind, randomized controlled trial was conducted with 320 patients, aged 65-80 years, ASA I-III, who were scheduled to undergoing LESS in our hospital were selected, the patients divided into Group R and Group G by random number table method, with 160 patients in each group. Group R was subjected to a bilateral RSB under ultrasound guidance after general anesthesia, each side was given 0.5% ropivacaine 10 ml. Group G received simple general anesthesia. The mini-mental State Examination was used to assess all the patients' primary cognitive status one day before surgery. Perioperative variables were recorded to be compared. The investigators used the visual analog scale to assess patients' pain degree with postoperative, using confusion assessment method to assess whether patients experienced delirium.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | December 5, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 80 Years |
Eligibility | Inclusion Criteria: - Aged 65 to 80 years male and female - Scheduled for elective single-incision laparoscopic cholecystectomy - The patients volunteered to participate in the study and signed the informed consent Exclusion Criteria: - Preexisting neuropathy - Coagulopathy - Local skin infection - Hepatic, renal or cardiorespiratory failure - Local anesthetic allergy - Pregnancy - Complications of gallstone with gallbladder perforation - Diffuse peritonitis - Acute pyogenic cholangitis |
Country | Name | City | State |
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China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital of Nantong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mini-mental State Examination | The mini-mental State Examination is effective as a screening tool for cognitive impairment with older, community dwelling, hospitalized and institutionalized adults. Assessment of an older adult's cognitive function is best achieved when it is done routinely, systematically and thoroughly. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (=9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age. | one day before the operation. | |
Primary | Change from Baseline visual analogue scale | Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | 30 minutes after extubation and 6 hours and 12 hours | |
Secondary | The effective times of patient-controlled intravenous analgesia | Change from Baseline patient-controlled intravenous analgesia | during 0-6 hours, 6-12 hours, and 12-24 hours |
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