Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.

Postoperative Pain Clinical Trial

— TAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976597
• Other study ID #: 17100234
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2016
• Est. completion date: July 2018

Study information

• Verified date: December 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine 0.25% 20ml on each side Sonar guided TAB
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
• Morphine 10mg
Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.
• Morphine 15mg
Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.

Locations

Country	Name	City	State
Egypt	Hala Saad Abdel-Ghaffar	Asyut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Rating Scale Score	The 24 hours postoperative verbal rating scale score on cough	24 hours
Secondary	Time to first request of rescue analgesia.	The total 24 hours consumption of analgesic drugs taken.	24 hours
Secondary	Time to first request of rescue analgesics.	The time from end of the operation, PACU admission and the request for analgesic drugs.	24 hours
Secondary	Spirometric assessment	Measurment of lung function by spirometry.	24 hours
Secondary	Adverse effects	Recording and treatment of adverse effects.	24 hours