Clinical trial NCT02976597: Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.
Official title: Morphine as an Adjunct in Sonar Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Keywords: Abdominal surgery, pain, local, transversus abdominus block.
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Verbal Rating Scale Score
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first request of rescue analgesia.
timeFrame: 24 hours
measure: Time to first request of rescue analgesics.
timeFrame: 24 hours
measure: Spirometric assessment
timeFrame: 24 hours
measure: Adverse effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Hala Saad Abdel-Ghaffar
state: Assiut Governorate
Study officials:
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: