Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery. (TAB)

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB; Drug: Morphine 10mg; Drug: Morphine 15mg

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut Governorate
    • Asyut, Assiut Governorate, Egypt, 715715
      • Hala Saad Abdel-Ghaffar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine 0.25%; 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; 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
Active Comparator: 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	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; Other Names: BUCAIN Sonar guided; Drug: Morphine 10mg; Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.; Other Names: Morphine injection
Active Comparator: 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	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; Other Names: BUCAIN Sonar guided; Drug: Morphine 15mg; Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.; Other Names: Morphine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Rating Scale Score	The 24 hours postoperative verbal rating scale score on cough	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdel-Ghaffar, MD, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Abdominal surgery, pain, local, transversus abdominus block.
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: 17100234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO