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Completed

NCT Number: NCT02976597

Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.

Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides adequate post-operative pain relieve following the various abdominal surgeries. Theoretically, TAP block may replace the need for epidural analgesia after abdominal operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior abdomen.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hala Saad Abdel-Ghaffar

Asyut, Assiut Governorate, 715715, Egypt

About this study

The transversus abdominis plane (TAP) technique, originally described by involves injection of local anaesthetic in the plane between the internal oblique and transversus abdominis muscle layers, with the aim of anaesthetising the intercostal nerves supplying the abdominal wall. Initially, the block used surface landmarks of the triangle of Petit (latissimus dorsi posteriorly, external oblique superiorly, iliac crest inferiorly) and a double fascial 'pop' (loss of resistance) to guide placement of the local anaesthetic. More recently, ultrasonography has been used to guide the delivery of the injectate into the appropriate plane, thereby increasing the accuracy of the Technique.

The duration of the TAB is limited to effect of administered local anesthetics. To prolong the block's duration, adjuvant medications were added to LA to magnify the effect of TAP block . Opiates such as morphine and tramadol have peripheral and central analgesic effects. Opiate receptors are present at the terminals of afferent peripheral nerves; therefore, administration of opiates peripherally might provide a significant analgesic effect.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

BMI< 30kg/m2.

  • Age: 18-60 years.
  • Sex: both males and females.
  • ASA physical status: 1-II.
  • Operation: Abdominal laparotomy.

Exclusion criteria

  • Patient refusal.
  • History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
  • Coagulation disorders.
  • Allergy to study medications.
  • Chronic use of pain medications.
  • Pregnancy.
  • Respiratory tract in-fection within the last 2 weeks.
  • Heavy smoker.
  • Histo-ry of abdominal surgery or trauma.

Treatment and study plan

Bupivacaine 0.25% 20ml on each side Sonar guided TAB

Drug

Bupivacaine 0.25% 20ml on each side Sonar guided TAP block. After careful aspiration injection of 20ml of 0.25% bupivacaine will be performed and hypoechoic layer will be detected on ultrasound then the maneuver will be repeated on the other side

Other names: BUCAIN Sonar guided

Morphine 10mg

Drug

Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.

Other names: Morphine injection

Morphine 15mg

Drug

Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.

Other names: Morphine injection

Primary outcomes

  1. Verbal Rating Scale Score

    Time frame: 24 hours

    The 24 hours postoperative verbal rating scale score on cough

Secondary outcomes

  1. Time to first request of rescue analgesia.

    Time frame: 24 hours

    The total 24 hours consumption of analgesic drugs taken.

  2. Time to first request of rescue analgesics.

    Time frame: 24 hours

    The time from end of the operation, PACU admission and the request for analgesic drugs.

  3. Spirometric assessment

    Time frame: 24 hours

    Measurment of lung function by spirometry.

  4. Adverse effects

    Time frame: 24 hours

    Recording and treatment of adverse effects.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Morphine as an Adjunct in Sonar Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgery.

Acronym: TAB

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Dec 31, 2018

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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