TAP Block for Gynaecological Laparotomies - a Comparison of Ultrasound-guided Block and Blind Technique

NCT00972920 | Completed

• 1 other identifier: 09/NIR03/45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Transversus abdominis plane (TAP) block is an application of local anaesthetic solution into the plane between internal oblique and transversus abdominis muscles at the triangle of Petit located superiorly to the iliac crests bilaterally. Anterior divisions of segmental spinal nerves, which provide innervation to the abdominal wall, run inside this compartment. TAP block been shown to provide good postoperative pain relief following surgical laparotomies, gynaecological laparotomies, appendicectomies, inguinal hernia repairs and open prostatectomies. The goal of this study is to compare the effect of blind and ultrasound-guided TAP block on postoperative pain relief and morphine consumption following to gynaecological laparotomies. Null research hypothesis for the study is that there is no difference between the performance (as defined by morphine consumption and patient satisfaction/ pain scores) of the TAP block procedure via 'blind' or ultrasound guided techniques for gynaecological laparotomies.

Conditions

Laparotomy

Keywords

Transversus abdominis plane; Acute pain service; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Total consumption of morphine for PCA within the first 12, 24 and 48 hours

  12, 24, 48 hours

Secondary Outcomes (4)

• Length of High Dependency Unit (recovery) stay

  once at discharge

• Length of hospital stay

  Once at discharge

• Visual Analog Scale (VAS) reading

  30min after operation and then at 1hr, 2hrs, 4hrs, 6hrs, 12hrs, 24hrs, 48 hrs

• Patient satisfaction

  12, 24 hrs

Study Arms (2)

Blind TAP block

ACTIVE COMPARATOR

TAP block technique as first described by McDonnell. Sterile field obtained with chlorhexidine wash and use of sterile gloves. Identification of triangle of Petit just above iliac crest and between external oblique and latissimus dorsi muscles. Insertion of regional anaesthesia needle perpendicular to skin, and its advancement until sensation of two 'pops' indicating advancement of needle through both external oblique and internal oblique muscle layers. After confirmation of negative aspiration the local anaesthetic is injected slowly, (1mg/kg of levobupivacaine), concentration 2.5 mg/mL. Repeat procedure bilaterally (to a maximum dose of 2mg/kg of levobupivacaine).

Procedure: Transversus abdominis plane (TAP) block

Ultrasound-guided TAP block

ACTIVE COMPARATOR

Technique as described by Hebbard. Sterile field obtained with chlorhexidine wash and use of sterile gloves. Ultrasound probe covered with sterile sheath. Identification of triangle of Petit with USS probe perpendicular to skin. Insertion of regional anaesthesia needle transversely to the probe, using in-plane (IP) technique, moving posteriorly. Advancement of the needle under ultrasound control until its tip is located between internal oblique and transversus abdominis muscle layers.

Procedure: Transversus abdominis plane (TAP) block

Interventions

Transversus abdominis plane (TAP) block PROCEDURE

Application of local anaesthetic solution (LA) levo-bupivacaine (dose 1mg/kg for each side, concentration 2.5 mg/mL) between internal oblique abdominis muscle and transversus abdominis muscle on both sides.

Also known as: TAP block

Blind TAP block; Ultrasound-guided TAP block

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of ASA status I-III
• Age 18-89 years
• Gynaecological laparotomies with a need for extensive postoperative analgesia.

You may not qualify if:

• Patient refusal
• Age less than 18 years or more than 89 years
• ASA status IV or V
• Patients with known reaction to local anaesthetics

Sponsors & Collaborators

• Northern Health and Social Care Trust: lead

Study Sites (1)

Antrim Area Hospital

Antrim, Co. Antrim, BT41 2RL, United Kingdom

Location

Related Publications (5)

• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

  PMID: 18020088 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

• McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.

  PMID: 18165577 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

• 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

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pavel Michalek, MD,PhD,DESA

  Antrim Area Hospital, Northern HSC Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Locum Consultant Anaesthetist

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

GB (1)