Laparoscopic Cholecystectomy and Quality of Recovery

NCT06321185 | Completed

• 1 other identifier: 2024/177
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 (QoR-15) scale

  Quality of Recovery-15 scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 0 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores. Postoperative score at the 24th hour will be assessed as the primary outcome.

  24 hours

Secondary Outcomes (4)

• Postoperative rescue analgesic requirement

  24 hours

• Consumption of postoperative opioid analgesics

  24 hours

• Numerical Rating Scale (NRS) scores

  24 hours

• Postoperative nausea and vomiting

  24 hours

Study Arms (3)

Subcostal TAP block

ACTIVE COMPARATOR

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

Procedure: Subcostal TAP block

Port site local anesthetic infiltration

ACTIVE COMPARATOR

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

Other: Port site local anesthetic infiltration

Standard multimodal IV analgesia

OTHER

There will not be an intervention or local anesthetic administration.

Other: No intervention or local anesthetic administration

Interventions

Subcostal TAP block 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.

Subcostal TAP block

Port site local anesthetic infiltration 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.

Port site local anesthetic infiltration

No intervention or local anesthetic administration 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.

Standard multimodal IV analgesia

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Officials

• Muserref B Dincer

  Istanbul University Istanbul Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The subcostal TAP block and port-site infiltration will be applied after the patient has general anesthesia, so the patient will not know the allocated group. The healthcare providers who work in the ward and are responsible for the analgesic treatments will be blinded to the patient's group. The outcomes assessor who will question the QoR-15 scale at the 24th hour will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Anesthesiologist

Model Details: The patients will be allocated randomly into three groups. Two groups will receive subcostal TAP block or port site local anesthetic infiltration, and the third group will not receive any intervention.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: March 25, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

TU (1)