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

NCT04641403 | Unknown

• 1 other identifier: MedicabilH
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transversus abdominis plane block, postoperative pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  he postoperative 1, 3, 6, 12, and 24-hour VAS scores (0 lowest-10 highest) at rest and on cough after surgery

  postoperatively 1,3,6,12 and 24 hours

Secondary Outcomes (1)

• satisfaction score

  postoperatively 24 hours

Study Arms (4)

Group 1 (Standard IV analgesia group (SA), n=40):

NO INTERVENTION

In this group, the block will be administered with normal saline (NS) and all port sites will be infiltrated with NS.

Group 2 (Local analgesia group (LA), n=40):

ACTIVE COMPARATOR

In this group, the block wiil be administered with NS and local anesthetic will be administered to the port sites.

Procedure: The surgeon performed Laparoscopic-assisted TAP (LTAP) block

Group 3 (two qudrant-Laparoscopic-assisted transversus abdominis plane block (LTAP) group, n=40)

EXPERIMENTAL

After the infiltration of all ports sites with NS, right sided two-quadrant block will be performed using bupivacaine.

Procedure: The surgeon performed Laparoscopic-assisted TAP (LTAP) block

roup 4 (Four qudrant-Laparoscopic-assisted transversus abdominis plane block (LTAP) group, n=40)

EXPERIMENTAL

After the infiltration of all ports sites with NS, bilateral four-quadrant block will be performed using bupivacaine.

Procedure: The surgeon performed Laparoscopic-assisted TAP (LTAP) block

Interventions

The surgeon performed Laparoscopic-assisted TAP (LTAP) block PROCEDURE

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.

Also known as: Standart İntravenous analgesia

Group 2 (Local analgesia group (LA), n=40):; Group 3 (two qudrant-Laparoscopic-assisted transversus abdominis plane block (LTAP) group, n=40); roup 4 (Four qudrant-Laparoscopic-assisted transversus abdominis plane block (LTAP) group, n=40)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society Anesthesia (ASA) 1 and 2 patients aged 18-70 years

You may not qualify if:

• \. Patients who did not agree to participate in the study, 2. ASA 3 and above patients, those who will undergone emergency surgery, open cholecystectomy 3. BMI of \>40, 4. İntraoperative major complications, 5. History of severe allergy, 6. Chronic analgesic use,

Sponsors & Collaborators

• Private Medicabil Hospital: lead

Study Sites (1)

Private Medicabil Hospital

Bursa, 16140, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Cevikkalp E, Narmanli M, Ozguc H, Ocakoglu G. Bilateral 4-quadrant laparoscopic-assisted transversus abdominis plane block reduces early postoperative pain after laparoscopic cholecystectomy: A prospective, single-blind, randomized study. Saudi Med J. 2023 Feb;44(2):145-154. doi: 10.15537/smj.2023.44.2.20220407.

  PMID: 36773971 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Halil Özgüç, md

  Medical Doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halil Özgüç, MD

CONTACT

00905323836464; ozguchalil@gmail.com

Mustafa Narmanlı, MD

CONTACT

00905332129331; mustafanarmanlı@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Anesthesia team, the patient, and the clinical nurses who carry out and record the postoperative evaluation will blinded to the group of patients.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: staff of general surgery

Model Details: prospective randomized double blind

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: September 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)