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

NCT ID: NCT05280860

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-12-05

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.

Detailed Description

1. Study design and setting 320 elderly patients undergoing LESS surgery under general anesthesia (including inguinal hernia and cholecystolithiasis), gender, aged 65-80 years, American Society of Anesthesiologists (ASA) physical status I-II. Exclusion criteria: MMSE of 1 day before surgery < 27, communication and dysfunction (e.g., vision, hearing), cerebrovascular history, local anesthetic allergy, opioid allergy, puncture site infection, abnormal clotting.

2. Subjects Patients were allocated randomly to R group (bilateral rectus abdominis sheath blocks combined with the general anesthesia group) and G group (the simple general anesthesia group) according to computer-generated random number table. All patients and an investigator who was responsible for follow-up during 48 postoperative hours were blinded to the randomization groups. In addition, during preoperative visits, the investigators instructed patients how to use the patient-controlled intravenous analgesia (PCA) device for pain management, as well as how to use the visual analog scale to evaluate pain at rest and while coughing. All the bispectral index (BIS) value in the present study was maintained between 40 and 60 during surgery. All patients voluntarily signed informed consent.

3. General anesthesia Patients were monitored by electrocardiogram, pulse oximetry and non-invasive blood pressure (one measurement every 3 min) while entering operation room. A radial artery catheter was also placed for invasive arterial pressure and blood gas monitoring. The induction of general anaesthesia was performed intravenously with sufentanil 0.5 µg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Endotracheal intubation was performed with a double-lumen tube. Sevoflurane was wsed at a minimal alveolar concentration (MAC) of 0.8-1, remifentanil and propofol were used for the maintenance. Fluid management was at the discretion of the attending anaesthesiologist.

Conditions

Delirium in Old Age; Hernia, Inguinal; Cholecystolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group R: bilateral RSB under ultrasound guidance after general anesthesia

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

Group Type: EXPERIMENTAL

ultrasound-guided bilateral rectus sheath block

Intervention Type: 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 G: simple general anesthesia

Group G received simple general anesthesia.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ultrasound-guided bilateral rectus sheath block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Zhang

Role: PRINCIPAL_INVESTIGATOR

Ethics Committee of Affiliated Hospital of Nantong University

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingguo Xu, Dr.

Role: CONTACT

xxgtdfy@163.com

18621526251

Facility Contacts

Xingguo Xu

Role: primary

xxgtdfy@163.com

18621526251

Other Identifiers

2020-k033

Identifier Type: -

Identifier Source: org_study_id