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NCT Number: NCT06684262

Intraperitoneal Local Anesthetic Infiltration Versus Erector Spinae Block in Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Postoperative Quality of Recovery Postoperative Analgesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality of postoperative recovery

    Time frame: postoperative 24th hour

    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.

Secondary outcomes

  1. Postoperative pain

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

    To evaluate and contrast the impact of Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration on postoperative pain levels during rest and movement, as measured by the numerical pain rating scale (ranging from 0 to 10, with 0 representing no pain and 10 representing the worst possible pain), among patients undergoing laparoscopic cholecystectomy.Higher numerical pain scale scores indicate higher pain levels, and lower scores indicate lower pain levels.

  2. Postoperative opioid consumption

    Time frame: for 24 hours postoperatively

    To compare the 24-hour postoperative morphine consumption in milligrams after Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Comparison of the Effect of Erector Spina Plane Block and Intraperitoneal Local Anesthetic Infiltration on the Quality of Postoperative Recovery in Patients Undergoing Laparoscopic Cholecystectomy.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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