Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB; Drug: Morphine 15mg; Drug: Morphine 10mg

• Registration Number: NCT02976597
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Primary Completion: 2018-06
• Study Completion: 2018-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine 10mg	Bupivacaine 0.25% 20ml on each side Sonar guided TAB	Morphine 10mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery.Patients will recieve 5mg morphine on each side
Morphine 15mg	Bupivacaine 0.25% 20ml on each side Sonar guided TAB	Morphine 15mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery. Patients will recieve 7.5mg morphine on each side
Bupivacaine 0.25%	Bupivacaine 0.25% 20ml on each side Sonar guided TAB	Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side on each side at end of the surgery.
Morphine 15mg	Morphine 15mg	Morphine 15mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery. Patients will recieve 7.5mg morphine on each side
Morphine 10mg	Morphine 10mg	Morphine 10mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery.Patients will recieve 5mg morphine on each side

Primary Outcome Measures

Name	Time	Method
Verbal Rating Scale Score	24 hours	The 24 hours postoperative verbal rating scale score on cough

Secondary Outcome Measures

Name	Time	Method
Spirometric assessment	24 hours	Measurment of lung function by spirometry.
Adverse effects	24 hours	Recording and treatment of adverse effects.
Time to first request of rescue analgesia.	24 hours	The total 24 hours consumption of analgesic drugs taken.
Time to first request of rescue analgesics.	24 hours	The time from end of the operation, PACU admission and the request for analgesic drugs.

Trial Locations

Locations (1)

Hala Saad Abdel-Ghaffar; 🇪🇬 Asyut, Assiut Governorate, Egypt