Laparoscopic Cholecystectomy and Quality of Recovery

March 25, 2024 updated by: Muserref Beril Dincer, Istanbul University

The Effects of Subcostal Transversus Abdominis Plane Block and Port-site Infiltration on the Quality of Recovery of Patients Undergoing Laparoscopic Cholecystectomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Recruiting
        • Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation
        • Contact:
        • Principal Investigator:
          • Muserref B Dincer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subcostal TAP block
Subcostal TAP block will be applied bilaterally with 20 ml 0.25% bupivacaine for each side.
Procedure: 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.
Active Comparator: Port site local anesthetic infiltration
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

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.
Other: Standard multimodal IV analgesia
There will not be an intervention or local anesthetic administration.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery-15 (QoR-15) scale
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative rescue analgesic requirement
Time Frame: 24 hours
IV 50 mg tramadol will be administered as a rescue analgesic when patients Numerical Rating Scale (NRS) score is 4 and higher.
24 hours
Consumption of postoperative opioid analgesics
Time Frame: 24 hours
IV 50 mg tramadol will be administered when patients Numerical Rating Scale (NRS) score is 4 and higher. Total given dose of tramadol will be questioned.
24 hours
Numerical Rating Scale (NRS) scores
Time Frame: 24 hours
On the Numerical Rating Scale, 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. Higher scores are related to severe pain.
24 hours
Postoperative nausea and vomiting
Time Frame: 24 hours
The presence of nausea and vomiting will be recorded postoperatively.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Muserref B Dincer, Istanbul University Istanbul Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

August 25, 2024

Study Completion (Estimated)

August 25, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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