Intraperitoneal Local Anesthetic Infiltration Versus Erector Spinae Block in Laparoscopic Cholecystectomy

NCT ID: NCT06684262

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2024-10-15

Brief Summary

Laparoscopic cholecystectomy is a commonly performed intra-abdominal surgical procedure all over the world. It may take an average of 4-5 weeks for patients to return to their pre-operative quality of life and standards after this surgery. Both Erector Spinae Plane Block and Intraperitoneal Local Anesthetic Infiltration method are methods used to reduce postoperative pain. However, there is no study in the literature comparing these 2 methods in terms of postoperative recovery quality. In this study, patients will receive Erector Spinae Plane Block or Intraperitoneal Local Anesthetic Infiltration at the end of surgery, and both techniques will be compared using the preoperative and postoperative quality of recovery 40 survey.

Detailed Description

The Preoperative Quality of Recovery 40 questionnaire will be administered to patients scheduled for laparoscopic cholecystectomy who consent to participate in the study. Following the surgical procedure, patients will receive either intraperitoneal local anesthetic infiltration or bilateral erector spinae plane block for postoperative analgesia. These interventions will be examined in an observational study comprising two distinct groups. At the 24-hour mark postoperatively, the Quality of Recovery 40 (QoR 40) survey will be readministered to the patients, and the outcomes will be subjected to comparative analysis. Throughout the postoperative period, patients in both cohorts will be closely monitored. Pain scores and opioid-associated adverse effects (such as nausea, vomiting, and pruritus) will be assessed at the 1st, 2nd, 4th, 8th, 12th, and 24th hours. Subsequent to the surgical procedure, patients in both groups will be provided with morphine via patient-controlled analgesia, and the extent of opioid consumption within the first 24 hours postoperatively will be compared.

Primary purpose: To compare the effects of Erector Spina Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy.

Secondary objectives: To compare the effects of ESP block and intraperitoneal local anesthetic infiltration on postoperative pain scores at rest and with movement, total opioid consumption, and incidence of opioid-related side effects in patients undergoing laparoscopic cholecystectomy.

Conditions

Postoperative Quality of Recovery; Postoperative Analgesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group IPLA

Following the extraction of the gallbladder, the surgical team promptly administers a 45 mL local anesthetic solution blend consisting of 20 mL of bupivacaine at a concentration of 0.5%, 10 mL of lidocaine at a concentration of 2%, and 15 mL of 0.9% saline solution to the gallbladder bed and subdiaphragmatic region. This administration is performed via an aspiration catheter under direct visualization provided by the laparoscopic camera

No interventions assigned to this group

Group ESP

At the end of the operation and before tracheal extubation, patients will be turned into the lateral decubitus position. Bilateral erector spinae plane block will be applied at the T8 spinous process level. Under asepsis-antisepsis standards, a 12 mHz linear ultrasound probe will be placed approximately 3 cm lateral to the spinous process of the T8 vertebra in a longitudinal parasagittal orientation. After identification of the trapezius, rhomboid major, erector spinae muscles and transverse process, an aspiration test using an 80 mm peripheral nerve block needle, 22.5 ml of local anesthetic mixture (10 mL bupivacaine at 0.5% concentration, 5 mL lidocaine at 2% concentration, 7.5 mL 0.9% NaCl) will be applied bilaterally.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Will undergo laparoscopic cholecystectomy operation,
• Patients with an American Society of Anesthesiologists Physical Status Score (ASA-PS) of 1, 2 and 3 will be included.

Exclusion Criteria

• Patients who do not give consent
• Those who are allergic to the drugs used in the research
• Those with coagulation disorders
• Having a history of alcohol and substance use
• Having a history of serious psychiatric and neurological diseases
• Having chronic pain syndrome
• Those with local infection in the area to be blocked
• Patients with sepsis and undergoing emergency surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Hakan Duzla MD

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara University Faculty of Medicine

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024000006-4

Identifier Type: -

Identifier Source: org_study_id