Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.

NCT02976597 | Completed Phase 2 DMC

• 1 other identifier: 17100234
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Abdominal surgery, pain, local, transversus abdominus block.

Outcome Measures

Primary Outcomes (1)

• Verbal Rating Scale Score

  The 24 hours postoperative verbal rating scale score on cough

  24 hours

Secondary Outcomes (4)

• Time to first request of rescue analgesia.

  24 hours

• Time to first request of rescue analgesics.

  24 hours

• Spirometric assessment

  24 hours

• Adverse effects

  24 hours

Study Arms (3)

Bupivacaine 0.25%

ACTIVE COMPARATOR

Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side on each side at end of the surgery.

Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB

Morphine 10mg

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB; Drug: Morphine 10mg

Morphine 15mg

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB; Drug: Morphine 15mg

Interventions

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

Also known as: BUCAIN Sonar guided

Bupivacaine 0.25%; Morphine 10mg; Morphine 15mg

Morphine 10mg DRUG

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

Also known as: Morphine injection

Morphine 10mg

Morphine 15mg DRUG

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

Also known as: Morphine injection

Morphine 15mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI\< 30kg/m2.
• Age: 18-60 years.
• Sex: both males and females.
• ASA physical status: 1-II.
• Operation: Abdominal laparotomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Hala Saad Abdel-Ghaffar

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 31, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)