Postoperative PainPhase 2/3TABNCT02976597
Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.
A Phase 2/3 study testing Bupivacaine 0.25% 20ml on each side Sonar guided TAB, Morphine 10mg and Morphine 15mg in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine 0.25% 20ml on each side Sonar guided TAB, Morphine 10mg and Morphine 15mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Jul 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI< 30kg/m2.
- Age: 18-60 years.
- Sex: both males and females.
- ASA physical status: 1-II.
- Operation: Abdominal laparotomy.
Who cannot join
- 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.
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- Respiratory tract in-fection within the last 2 weeks.
- Heavy smoker.
- Histo-ry of abdominal surgery or trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine 0.25% 20ml on each side Sonar guided TAB, Morphine 10mg, Morphine 15mg
- Keywords
- Abdominal surgery, pain, local, transversus abdominus block.
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% 20ml on each side Sonar guided TABDrug
Also called BUCAIN Sonar guided
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 10mgDrug
Also called Morphine injection
Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.
Morphine 15mgDrug
Also called Morphine injection
Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB; Drug: Morphine 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Rating Scale Score
The 24 hours postoperative verbal rating scale score on cough
Measured: 24 hours
Secondary outcomes (4)
Time to first request of rescue analgesia.
The total 24 hours consumption of analgesic drugs taken.
Measured: 24 hours
Time to first request of rescue analgesics.
The time from end of the operation, PACU admission and the request for analgesic drugs.
Measured: 24 hours
Spirometric assessment
Measurment of lung function by spirometry.
Measured: 24 hours
Adverse effects
Recording and treatment of adverse effects.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976597
- Sponsor's protocol ID
- 17100234
- Acronym
- TAB
- Status last verified
- Dec 2018
- First submitted
- 24 Nov 2016
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine as an Adjunct in Sonar Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT02976597
- Acronym / sponsor ID
- TAB / 17100234
- Conditions
- Postoperative Pain
- Keywords
- Abdominal surgery, pain, local, transversus abdominus block.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0.25% | Active comparator | Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TABBupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side on each side at end of the surgery. |
| Morphine 10mg | Active comparator | Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB, Drug: Morphine 10mgMorphine 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 | Active comparator | Drug: Bupivacaine 0.25% 20ml on each side Sonar guided TAB, Drug: Morphine 15mgMorphine 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI< 30kg/m2.
- Age: 18-60 years.
- Sex: both males and females.
- ASA physical status: 1-II.
- Operation: Abdominal laparotomy.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine 0.25% 20ml on each side Sonar guided TABAlso: BUCAIN Sonar guidedBupivacaine 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 | Drug | Bupivacaine 0.25%, Morphine 10mg, Morphine 15mg |
| Morphine 10mgAlso: Morphine injectionMorphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side. | Drug | Morphine 10mg |
| Morphine 15mgAlso: Morphine injectionMorphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side. | Drug | Morphine 15mg |
Primary outcome
Verbal Rating Scale Score
Time frame: 24 hours
The 24 hours postoperative verbal rating scale score on cough
4 secondary outcomes
Time to first request of rescue analgesia.
Time frame: 24 hours
Time to first request of rescue analgesics.
Time frame: 24 hours
Spirometric assessment
Time frame: 24 hours
Adverse effects
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala S Abdel-Ghaffar, MD principal investigator
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine 0.25% 20ml on each side Sonar guided TAB, Morphine 10mg and Morphine 15mg in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Rating Scale Score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.