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

Sponsor
Northern Health and Social Care Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00972920
Collaborator
(none)
120
1
2
34
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transversus abdominis plane (TAP) block
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Transversus Abdominis Plane (TAP) Block for Gynaecological Laparotomies - a Comparison of Ultrasound-guided Block and Blind Technique
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • TAP block
  • Outcome Measures

    Primary Outcome Measures

    1. Total consumption of morphine for PCA within the first 12, 24 and 48 hours [12, 24, 48 hours]

    Secondary Outcome Measures

    1. Length of High Dependency Unit (recovery) stay [once at discharge]

    2. Length of hospital stay [Once at discharge]

    3. Visual Analog Scale (VAS) reading [30min after operation and then at 1hr, 2hrs, 4hrs, 6hrs, 12hrs, 24hrs, 48 hrs]

    4. Patient satisfaction [12, 24 hrs]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Antrim Area Hospital Antrim Co. Antrim United Kingdom BT41 2RL

    Sponsors and Collaborators

    • Northern Health and Social Care Trust

    Investigators

    • Principal Investigator: Pavel Michalek, MD,PhD,DESA, Antrim Area Hospital, Northern HSC Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Pavel Michalek, Locum Consultant Anaesthetist, Northern Health and Social Care Trust
    ClinicalTrials.gov Identifier:
    NCT00972920
    Other Study ID Numbers:
    • 09/NIR03/45
    First Posted:
    Sep 9, 2009
    Last Update Posted:
    Oct 21, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Dr. Pavel Michalek, Locum Consultant Anaesthetist, Northern Health and Social Care Trust

    Study Results

    No Results Posted as of Oct 21, 2015