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Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.

NCT ID: NCT02976597

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Keywords

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Abdominal surgery, pain, local, transversus abdominus block.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25% 20ml on each side Sonar guided TAB

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25% 20ml on each side Sonar guided TAB

Intervention Type 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

Morphine 10mg

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25% 20ml on each side Sonar guided TAB

Intervention Type 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

Morphine 15mg

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Morphine 10mg

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

Intervention Type DRUG

Morphine 15mg

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

Intervention Type DRUG

Other Intervention Names

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BUCAIN Sonar guided Morphine injection Morphine injection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hala Saad Abdel-Ghaffar

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hala Saad Abdel-Ghaffar

Asyut, Assiut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17100234

Identifier Type: -

Identifier Source: org_study_id