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"The Efficiency of Laparoscopic-assisted Transversus Abdominis Plane Block for Post-laparoscopic Cholecystectomy Pain

NCT04641403 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-09-10

No results posted yet for this study

Summary

Laparoscopic cholecystectomy (LC) is a minimally invasive surgical procedure that causes moderate pain in the early postoperative period. In this prospective randomized study, the efficacy of four-quadrant and two-quadrant laparoscopic-assisted transversus abdominis plane (LTAP) block on postoperative pain will be compared with that of only intravenous analgesia (SA) and port-site infiltration of local anesthetic (LA).

Patients undergoing elective LC will be divided into four groups of 40 patients each using a randomization scale. The standard analgesia group will receive LTAP block with normal saline (NS) and port-site infiltration of NS, the LA group will receive LTAP block with NS and port-site infiltration of bupivacaine, while the four and two quadrant LTAP group will receive the block with bupivacaine and port-site infiltration of NS. Postoperative analgesia will be administered to all groups as a standard procedure. The patients' demographic data, postoperative 1, 3, 6, 12, and 24-hour visual analog pain (VAS) scores at rest and on cough, opioid requirement, presence of nausea and vomiting, and satisfaction scores will record in a standard form. The statistical analysis will be carried out using the SPSS software and the level of significance was set at p\<0.05.

Conditions

  • Postoperative Pain

Interventions

PROCEDURE

The surgeon performed Laparoscopic-assisted TAP (LTAP) block

After the induction of anesthesia, the first port will be inserted through the umbilicus and a 12 mmHg pneumoperitoneum will establish as a standard. Under the direct view of the laparoscopic camera, the block will be performed by inserting a 22-G needle just above the iliac crest through the midclavicular line posteriorly into the triangle of Petit and then inserting the needle below the costal arch through the midclavicular line towards the anterior axillary line into the subcostal plane. The block needle will be advanced under direct view until the two pops were felt and the extraperitoneal space will reach without puncturing the parietal peritoneum, and pulling back the needle 0.5 cm, the area of the thin transversus abdominis muscle fibers wiil be infiltrated. In this area, the correct plane of the needle tip will confirm by observing Doyle's bulge and the spread of the local anesthetic.

Sponsors & Collaborators

  • Private Medicabil Hospital

    lead OTHER

Principal Investigators

  • Halil Özgüç, md · Medical Doctor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641403 on ClinicalTrials.gov