Clinical trial NCT06684262: Intraperitoneal Local Anesthetic Infiltration Versus Erector Spinae Block in Laparoscopic Cholecystectomy
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Quality of postoperative recovery
timeFrame: postoperative 24th hour
Secondary outcomes:
measure: Postoperative pain
timeFrame: Postoperative 1st-2nd-4th-8th-12th-24th hours
measure: Postoperative opioid consumption
timeFrame: for 24 hours postoperatively
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
Study officials:
References: