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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.25% 20ml on each side Sonar guided TAB
Morphine 10mg
Morphine 15mg
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Abdominal surgery, pain, local, transversus abdominus block.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hala Saad Abdel-Ghaffar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bupivacaine 0.25%

Morphine 10mg

Morphine 15mg

Arm Description

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

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2016
Last Updated
December 27, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02976597
Brief Title
Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.
Acronym
TAB
Official Title
Morphine as an Adjunct in Sonar Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Abdominal surgery, pain, local, transversus abdominus block.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine 0.25%
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side on each side at end of the surgery.
Arm Title
Morphine 10mg
Arm Type
Active Comparator
Arm Description
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
Arm Title
Morphine 15mg
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% 20ml on each side Sonar guided TAB
Other Intervention Name(s)
BUCAIN Sonar guided
Intervention Description
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
Intervention Name(s)
Morphine 10mg
Other Intervention Name(s)
Morphine injection
Intervention Description
Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.
Intervention Type
Drug
Intervention Name(s)
Morphine 15mg
Other Intervention Name(s)
Morphine injection
Intervention Description
Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.
Primary Outcome Measure Information:
Title
Verbal Rating Scale Score
Description
The 24 hours postoperative verbal rating scale score on cough
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to first request of rescue analgesia.
Description
The total 24 hours consumption of analgesic drugs taken.
Time Frame
24 hours
Title
Time to first request of rescue analgesics.
Description
The time from end of the operation, PACU admission and the request for analgesic drugs.
Time Frame
24 hours
Title
Spirometric assessment
Description
Measurment of lung function by spirometry.
Time Frame
24 hours
Title
Adverse effects
Description
Recording and treatment of adverse effects.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdel-Ghaffar, MD
Organizational Affiliation
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hala Saad Abdel-Ghaffar
City
Asyut
State/Province
Assiut Governorate
ZIP/Postal Code
715715
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.

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