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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Northern Health and Social Care Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northern Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT00972920
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Laparotomy
Procedure: Transversus abdominis plane (TAP) block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane (TAP) Block for Gynaecological Laparotomies - a Comparison of Ultrasound-guided Block and Blind Technique

Resource links provided by NLM:


Further study details as provided by Northern Health and Social Care Trust:

Primary Outcome Measures:
  • Total consumption of morphine for PCA within the first 12, 24 and 48 hours [ Time Frame: 12, 24, 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of High Dependency Unit (recovery) stay [ Time Frame: once at discharge ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Once at discharge ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) reading [ Time Frame: 30min after operation and then at 1hr, 2hrs, 4hrs, 6hrs, 12hrs, 24hrs, 48 hrs ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 12, 24 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blind TAP block

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
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.
Other Name: TAP block
Active Comparator: Ultrasound-guided TAP block

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
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.
Other Name: TAP block

Detailed Description:

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. The TAP block has been shown to provide good postoperative pain relief following surgical laparotomies, gynaecological laparotomies, appendicectomies, inguinal hernia repairs and open prostatectomies. It also reduces the post operative morphine consumption seen after such procedures. This allows a more comfortable recovery with reduced incidence of nausea and vomiting, as well as potentially earlier mobilisation and discharge.

Currently the technique employed is that first described by Mc Donnell. This involves a blind 'two pop' technique signifying the needle passing through the two muscle layers. On detection of these two pops the local anaesthetic is injected into this plane between the muscle layers. It is the anaesthetising of the nerves in this muscle plane that aides post operative pain relief for as much as 24 hours. TAP nerve blocks have become common practice due to the very low reported complication rate occurring while using the 'blind technique'. Such complications are minor in themselves. It is our hope that these complications will be further reduced with the use of an ultrasound guided technique. The use of an ultrasound machine would allow the direct visualisation of the needles progress through the tissues and muscle layers. It would confirm the correct position during infiltration of local anaesthetic and prevent inadvertent puncturing of organs or entry to the abdominal space.

Studies have shown that in other commonly used nerve blocks, the introduction of an ultrasound guided technique has improved the efficacy of the nerve block itself. We hope to show a similar trend when using an ultrasound guided technique in the insertion of a TAP block. Trials are underway comparing different dosage and volume regimes, but to our knowledge no other trial is comparing the use of an ultrasound machine to the conventional 'blind' technique in order to assess pain relief and morphine consumption post operatively.

Only recently have ultrasound machines become commonplace in anaesthetic departments, and we feel this research will show their valuable contribution to patient comfort in this subgroup of patients undergoing abdominal gynaecological procedures. We wish to assess whether we can achieve better patient satisfaction, less morphine consumption and ultimately shorter hospital stay with an ultrasound technique compared to a blind technique.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  • Age less than 18 years or more than 89 years
  • ASA status IV or V
  • Patients with known reaction to local anaesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972920

Contacts
Contact: Pavel Michalek, MD,PhD,DESA +442894424249 pafkamich@yahoo.co.uk
Contact: Alexander Abraham, MB,FRCA +442894424249 alexander.abraham@northerntrust.hscni.net

Locations
United Kingdom
Antrim Area Hospital Recruiting
Antrim, Co. Antrim, United Kingdom, BT41 2RL
Contact: Pavel Michalek, MD,PhD,DESA    +442894424249    pafkamich@yahoo.co.uk   
Contact: Alexander Abraham, MB, FRCA    +442894424249    alexander.abraham@northerntrust.hscni.net   
Principal Investigator: Pavel Michalek, MD,PhD,DESA         
Sub-Investigator: Alexander Abraham, MB,FRCA         
Sub-Investigator: Conor Farrell, MB,FCARCSI         
Sub-Investigator: Francis McAleavey, MBBCh         
Sponsors and Collaborators
Northern Health and Social Care Trust
Investigators
Principal Investigator: Pavel Michalek, MD,PhD,DESA Antrim Area Hospital, Northern HSC Trust
  More Information

Publications:
Responsible Party: Dr Pavel Michalek - Consultant Anaesthetist, Antrim Area Hospital, Northern HSC Trust
ClinicalTrials.gov Identifier: NCT00972920     History of Changes
Other Study ID Numbers: 09/NIR03/45
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: United Kingdom: Department of Health

Keywords provided by Northern Health and Social Care Trust:
Transversus abdominis plane
Acute pain service
Ultrasound

ClinicalTrials.gov processed this record on October 22, 2014