Laparoscopic Cholecystectomy and Quality of Recovery

NCT ID: NCT06321185

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2025-04-10

Brief Summary

This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port sites, and the third group will receive only IV analgesics.

Detailed Description

There are current approaches that search patients' perspectives to assess postoperative outcomes. In this regard, patient-centered outcomes are evaluated in clinical trials. It is recommended that patient comfort be assessed for short-term recovery after surgery. The Quality of Recovery-15 (QoR-15) scale is a defined patient comfort endpoint. This scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 1 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores.

The subcostal transversus abdominis plane ( Subcostal TAP) block is used for analgesia in abdominal surgeries, including laparoscopic cholecystectomy. Local anesthetics are injected between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. Local anesthetic infiltration into the laparoscopic port sites is also used for analgesia in laparoscopic cholecystectomy.

The primary outcome of this study is to evaluate the effects of subcostal TAP block and port-site infiltration on the quality of recovery of patients undergoing laparoscopic cholecystectomy. Secondary outcomes are to evaluate Numerical Rating Scale (NRS) scores at time intervals, postoperative rescue analgesic requirement, total consumption of postoperative opioid analgesics, and presence of nausea and vomiting, for the postoperative 24 hours.

This study will be conducted as a prospective randomized clinical trial. The patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After assessment for eligibility, the patients will be randomly allocated into three groups.

For the first group, a subcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. For the second group, after intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. The third group will not have an intervention or local anesthetic administration, and a multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol). This IV analgesic regimen will be applied to all patients included in the study. The patients will not know to which group they are allocated. Standard anesthesia protocol will be applied to all patients.

At the ward, patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam. At the Numerical Rating Scale (NRS), pain is rated on a scale from 0 (no pain) to 10 (worst pain) and will be assessed at time intervals both at rest and during movement for postoperative 24 hours. A rescue analgesic IV 50 mg tramadol will be applied if it is four or higher. The healthcare provider will be blinded to which group the patient is in. All NRS scores, the requirement for rescue analgesics and total consumption, and the presence of nausea and vomiting for the postoperative 24 hours will be recorded by blind outcome assessors.

The Quality of Recovery-15 (QoR-15) scale will be evaluated before the surgery in the waiting area and at the postoperative 24th hour in the ward. The outcome assessor questioning QoR-15 will be blinded to which group the patient is allocated to.

Conditions

Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Subcostal TAP block

Subcostal TAP block will be applied bilaterally with 20 ml 0.25% bupivacaine for each side.

Group Type: ACTIVE_COMPARATOR

Subcostal TAP block

Intervention Type: PROCEDURE

Subcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).

Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.

Port site local anesthetic infiltration

A total solution of 20 ml 0.25% bupivacaine will be infiltrated into the port sites before port placements.

Group Type: ACTIVE_COMPARATOR

Port site local anesthetic infiltration

Intervention Type: OTHER

After intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).

Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.

Standard multimodal IV analgesia

There will not be an intervention or local anesthetic administration.

Group Type: OTHER

No intervention or local anesthetic administration

Intervention Type: OTHER

There will not be an intervention or local anesthetic administration. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).

Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.

Interventions

Subcostal TAP block

Subcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).

Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.

Intervention Type: PROCEDURE

Port site local anesthetic infiltration

After intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).

Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.

Intervention Type: OTHER

No intervention or local anesthetic administration

There will not be an intervention or local anesthetic administration. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).

Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for elective laparoscopic cholecystectomy
• Patients aged 18 to 80
• American Society of Anesthesiology (ASA) physical status I-II
• Signed informed consent

Exclusion Criteria

• Patient refusal and inability to provide informed consent
• Known allergy to local anesthetics
• Severe kidney or liver disease
• Altered level of consciousness
• Inability to communicate due to language barrier
• Diagnosis of mental or psychiatric disorder
• Presence of coagulation disorder
• Contraindications to regional anesthesia
• Contraindications to any drug applying in the study
• Presence of coagulation disorder
• Chronic opioid intake
• Body mass index (BMI) ≥ 40 kg/m2
• History of alcohol or drug abuse
• Changed surgical technique from laparoscopic to open.

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

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Muserref Beril Dincer

Medical Doctor, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muserref B Dincer

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Istanbul Medical Faculty

Locations

Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024/177

Identifier Type: -

Identifier Source: org_study_id