Comparison of Abdominal Plane Blocks in Postoperative Pain Control in Patients Undergoing LSG

NCT06201546 | Completed

• 1 other identifier: gamzenurteke-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational study is compare in terms of efficiency and complications transversus abdominis plane (TAP) and Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) blocks in patients undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analgesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.

Conditions

Bariatric Surgical Procedures; Anesthesia and Analgesia; Anesthesia, Regional

Keywords

LSG; TAP; m-TAPA; pain manangement; plane block

Outcome Measures

Primary Outcomes (3)

• Numeric Rate Score (NRS)

  NRS is a 0 to 10 scale that describes pain from good to worst.

  It will be evaluated with (which ), at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

• Visual Analog Scale (VAS)

  VAS is a 10-centimeter scale and is used to evaluate pain.

  PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

• Pain Controlled Analgesia (PCA)

  PCA is includes 300mg Tramadol/100 ml SF- no infusion, 5cc bolus, 15 minutes lock

  PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

Secondary Outcomes (1)

• postoperative nausea and vomiting scale (PNV)

  It will be evaluated with nause and vomiting score at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

Study Arms (2)

TAP block

ACTIVE COMPARATOR

Transversus Abdominal Plane Block aplied after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia.

Procedure: TAP block group

m-TAPA block

ACTIVE COMPARATOR

Modified-Thoracoabdominal Plane Block-pericondrial approach aplied after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region.

Procedure: m-TAPA block group

Interventions

TAP block group PROCEDURE

TAP block will be administrated after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia.

TAP block

m-TAPA block group PROCEDURE

m-TAPA block will be administrated after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region

m-TAPA block

Eligibility Criteria

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

You may qualify if:

• Patients between the ages of 18-65, including the ASA I-III group, who underwent laparoscopic sleeve gastrectomy by the General Surgery clinic between January 26, 2023 and May 15, 2023

You may not qualify if:

• Patients with coronary artery disease
• Patients with cerebrovascular disease
• Patients with peripheral artery disease
• History of chronic analgesic use
• Patients with coagulopathy
• Patients not between the ages of 18-65
• Patients with hepatic and/or renal insufficiency
• Patients with missing information in the information form

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Gamze Nur Teke

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.

  PMID: 16418039 BACKGROUND

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 BACKGROUND

• McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

  PMID: 17961838 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• arzu yıldırım ar

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Due to the double-blind nature of the study, the outcome of the effectiveness of plane blocks will not be known by the anesthesiologist and the patient until the end of the study. Only the effectiveness of blocks will be followed by an another researcher
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, assistant doctor

Model Details: Clinical trial in which two groups of participants who are applied two type plane blocks. Group A; TAP block and group B; m-TAPA block. Effectiveness of blocks will be followed by appliying Pain Controlled Analgesia(PCA) and with pain scales as Visual Analog Scale(VAS) and Numerating Rate Scale.

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: January 11, 2024
• Study Start: February 25, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: April 4, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)