Intraperitoneal Local Anesthetic Infiltration Versus Erector Spinae Block in Laparoscopic Cholecystectomy

NCT06684262 | Completed

• 1 other identifier: 2024000006-4
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Quality of Recovery; Postoperative Analgesia

Keywords

Erector Spina Plane Block; intraperitoneal instillation of local anesthetics; Postoperative quality of recovery; Postoperative analgesia; laparoscopic cholecystectomy; intraperitoneal infiltration of local anaesthetic

Outcome Measures

Primary Outcomes (1)

• Quality of postoperative recovery

  The aim of this study was to use the Quality of Recovery 40 questionnaire as a method to evaluate and compare the effects of Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy. The QoR-40 questionnaire is a self-assessment questionnaire used to evaluate the quality of postoperative recovery. It is a questionnaire that evaluates the level of pain, physical and emotional status of patients and consists of 40 questions and five domains: emotional status (n=9), comfort (n=12), psychological support (n=7), physical independence (n=5) and pain (n=7). Each question is scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 40 (worst quality of recovery) to 200 (best quality of recovery). A low total score indicates poor quality of recovery; a high total score indicates good quality of recovery.

  postoperative 24th hour

Secondary Outcomes (2)

• Postoperative pain

  Postoperative 1st-2nd-4th-8th-12th-24th hours

• Postoperative opioid consumption

  for 24 hours postoperatively

Study Arms (2)

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: November 12, 2024
• Study Start: February 16, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

TU (1)