Clinical Trials Directory

Trials / Completed

CompletedNCT06684262

Intraperitoneal Local Anesthetic Infiltration Versus Erector Spinae Block in Laparoscopic Cholecystectomy

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.

Status
Completed
Phase
Study type
Observational
Enrollment
82 (actual)
Sponsor
Ankara University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2024-02-16
Primary completion
2024-10-15
Completion
2024-10-15
First posted
2024-11-12
Last updated
2024-11-12

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06684262. Inclusion in this directory is not an endorsement.