Acute PainPhase 4NCT02645903
Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy
A Phase 4 study testing Transversus Abdominis Plane Block and standard general anesthesia in people with Acute Pain, run by Inonu University.
Trial summary
Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Transversus Abdominis Plane Block and standard general anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver transplantation donors
Who cannot join
- Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance
About this study
Official title: Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy: Randomized Controlled Double-blinded Trial
Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.
Read the detailed description
This prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. Cases to whom TAP block with ultrasound was applied after standard general anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was applied, were determined as Group 2.
- Conditions
- Acute Pain
- Being tested
- Transversus Abdominis Plane Block, standard general anesthesia
- Keywords
- transversus abdominis plane block, living liver transplantation, postoperative analgesia
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane BlockDrug
Also called Marcaine plain+morphine
Cases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1
standard general anesthesiaDrug
Also called morphine
Cases to whom applied alone standard general anesthesia were determined as Group 2
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominis plane block | Active comparator | Patients who received a tranversus abdominis plane block with ultrasound after standard general anesthesia represented Group 1.
The tranversus abdominis plane block was performed bilaterally by obtaining an image with real time ultrasound guidance with a 6-13 MHz linear probe.
The block was placed with a 22 G 80 mm needle while obtaining real-time images via an in-plane technique.
Two 20 mL syringes were prepared after preparing a local anesthetic concentration of 1.5 mg/kg of 0.5% bupivacaine to 40 mL with saline. These were administered to the left and right abdominal walls.
Postoperative analgesia was administered through a morphine the patient-controlled analgesia device. Receives: Drug: Transversus Abdominis Plane Block |
| nonblocked | Placebo comparator | Patients who received standard general anesthesia alone made up Group 2. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device. Receives: Drug: standard general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores (at movement and at rest)
Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).
Measured: postoperatively at 24 hours
Secondary outcomes (1)
morphine consumption
morphine consumption were measured in postoperatively 24 hours
Measured: postoperatively at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Inonu 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Erdoğan, Inonu University
- Investigators
- Mehmet Ali Erdogan, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645903
- Sponsor's protocol ID
- TAP
- Status last verified
- Jan 2016
- First submitted
- 24 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.
PubMed 22286518
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy: Randomized Controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT02645903
- Acronym / sponsor ID
- TAP
- Conditions
- Acute Pain
- Keywords
- transversus abdominis plane block, living liver transplantation, postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Jan 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.
Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.
Detailed description
This prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. Cases to whom TAP block with ultrasound was applied after standard general anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was applied, were determined as Group 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus abdominis plane block | Active comparator | Drug: Transversus Abdominis Plane BlockPatients who received a tranversus abdominis plane block with ultrasound after standard general anesthesia represented Group 1. The tranversus abdominis plane block was performed bilaterally by obtaining an image with real time ultrasound guidance with a 6-13 MHz linear probe. The block was placed with a 22 G 80 mm needle while obtaining real-time images via an in-plane technique. Two 20 mL syringes were prepared after preparing a local anesthetic concentration of 1.5 mg/kg of 0.5% bupivacaine to 40 mL with saline. These were administered to the left and right abdominal walls. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device. |
| nonblocked | Placebo comparator | Drug: standard general anesthesiaPatients who received standard general anesthesia alone made up Group 2. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver transplantation donors
Key exclusion criteria (1 listed)
- Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance
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 |
|---|---|---|
| Transversus Abdominis Plane BlockAlso: Marcaine plain+morphineCases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1 | Drug | transversus abdominis plane block |
| standard general anesthesiaAlso: morphineCases to whom applied alone standard general anesthesia were determined as Group 2 | Drug | nonblocked |
Primary outcome
pain scores (at movement and at rest)
Time frame: postoperatively at 24 hours
Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).
1 secondary outcome
morphine consumption
Time frame: postoperatively at 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 6 Jan 2016.
- Results publication: PubMed 22286518Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.
- 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.
Mehmet Ali Erdogan principal investigator
Inonu University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transversus Abdominis Plane Block and standard general anesthesia in people with Acute Pain, run by Inonu University.
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 1 inclusion and 1 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
pain scores (at movement and at rest) (time frame: postoperatively at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645903, which also lists 1 linked publication.
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 6 Jan 2016.