Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy

NCT02645903 | Completed Phase 4

• 1 other identifier: TAP
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.

Conditions

Acute Pain

Keywords

transversus abdominis plane block; living liver transplantation; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• pain scores (at movement and at rest)

  Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).

  postoperatively at 24 hours

Secondary Outcomes (1)

• morphine consumption

  postoperatively at 24 hours

Study Arms (2)

transversus abdominis plane block

ACTIVE COMPARATOR

Patients who received a tranversus abdominis plane block with ultrasound after standard general anesthesia represented Group 1. The tranversus abdominis plane block was performed bilaterally by obtaining an image with real time ultrasound guidance with a 6-13 MHz linear probe. The block was placed with a 22 G 80 mm needle while obtaining real-time images via an in-plane technique. Two 20 mL syringes were prepared after preparing a local anesthetic concentration of 1.5 mg/kg of 0.5% bupivacaine to 40 mL with saline. These were administered to the left and right abdominal walls. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device.

Drug: Transversus Abdominis Plane Block

nonblocked

PLACEBO COMPARATOR

Patients who received standard general anesthesia alone made up Group 2. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device.

Drug: standard general anesthesia

Interventions

Transversus Abdominis Plane Block DRUG

Cases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1

Also known as: Marcaine plain+morphine

transversus abdominis plane block

standard general anesthesia DRUG

Cases to whom applied alone standard general anesthesia were determined as Group 2

Also known as: morphine

nonblocked

Eligibility Criteria

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

You may qualify if:

• Liver transplantation donors

You may not qualify if:

• Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance

Sponsors & Collaborators

• Inonu University: lead

Related Publications (1)

• Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.

  PMID: 22286518 RESULT

MeSH Terms

Conditions

Acute Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mehmet Ali Erdogan

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associted professor

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 5, 2016
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 6, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share