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Completed

NCT Number: NCT00972920

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

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.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antrim Area Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: TAP block

Primary outcomes

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

    Time frame: 12, 24, 48 hours

Secondary outcomes

  1. Length of High Dependency Unit (recovery) stay

    Time frame: once at discharge

  2. Length of hospital stay

    Time frame: Once at discharge

  3. Visual Analog Scale (VAS) reading

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

  4. Patient satisfaction

    Time frame: 12, 24 hrs

Sponsors and collaborators

Lead sponsor

Northern Health and Social Care Trust

Other Gov

Registry information

Official study title

Transversus Abdominis Plane (TAP) Block for Gynaecological Laparotomies - a Comparison of Ultrasound-guided Block and Blind Technique

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2009
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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