Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery

NCT05280860 | Unknown

• 1 other identifier: 2020-k033
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium in Old Age; Hernia, Inguinal; Cholecystolithiasis

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• The effective times of patient-controlled intravenous analgesia

  during 0-6 hours, 6-12 hours, and 12-24 hours

Study Arms (2)

Group R: bilateral RSB under ultrasound guidance after general anesthesia

EXPERIMENTAL

Group R was subjected to a bilateral RSB under ultrasound guidance after general anesthesia.

Procedure: ultrasound-guided bilateral rectus sheath block

Group G: simple general anesthesia

NO INTERVENTION

Group G received simple general anesthesia.

Interventions

ultrasound-guided bilateral rectus sheath block PROCEDURE

Bilateral RSB was guided by ultrasound before surgery after the completion of general anesthesia, First, the probe is placed transversely and perpendicular to reveal the anterior, hypoechoic, and posterior rectus sheath of the hyperechoic rectus abdominis. Moving the probe outward to reveal the sound images of the lateral margin of the rectus abdominis, external oblique, internal oblique, and transverse abdominis muscles. After the scanning, the needle was inserted from any segment of the probe under the guidance of real-time ultrasound; the tip reached between the rectus abdominis muscle and the posterior sheath of the rectus abdominis muscle. After no blood was extracted, 1 \~ 2 ml of normal saline was firstly injected to determine whether the tip position was correct, If the needle tip was correctly positioned, 0.5 % ropivacaine 10 mL of local anesthetic was injected on each side. The same anesthesiologist was performed bilateral RSB under ultrasound guidance.

Group R: bilateral RSB under ultrasound guidance after general anesthesia

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 0513, China

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal; Cholecystolithiasis

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Tao Zhang

  Ethics Committee of Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingguo Xu, Dr.

CONTACT

18621526251; xxgtdfy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: March 15, 2022
• Study Start: November 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 5, 2022
• Last Updated: May 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)