Postoperative Nausea and VomitingPhase 3USGNCT02331563
Adjuvant Effect of Dexmedetomidine in Ultrasound (USG) Guided Transvers Abdominis Plane Block
A Phase 3 study testing Dexmedetomidine and 0.25 % bupivacaine in people with Postoperative Nausea and Vomiting, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D (n = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dexmedetomidine and 0.25 % bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2014to Nov 2015
- Phase
- Phase 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients undergoing laparascopic cholecystectomy
Who cannot join
- Story of allergy to bupivacaine and dexmedetomidine
- The surgery preceeded to laparatomy
- Recent abdominal operation history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University School of Medicine Department of Anaesthesiology and Reanimation
Kirikkale, Yahşihan, 71451
About this study
Official title: Adjuvant Effect of Dexmedetomidine for the Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Laparascopic Cholecystectomy: a Randomized Controlled Clinical Trial.
A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D (n = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general anaesthesia. Total local anaesthetic volume was standardised with 20 ml each sides of the abdomen. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4, 5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.
Read the detailed description
Transversus abdominis plane (TAP) block has been shown to provide postoperative pain relief following various abdominal and inguinal surgeries. The aim of this randomised controlled trial was to assess the effect of transversus abdominis plane (TAP) blocks on opioid requirements and median hospitai stay, postoperative nause and vomitting in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Dexmedetomidine, 0.25 % bupivacaine
- Keywords
- dexmedetomidine
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
ultrasound guided transvers abdominis plane block
0.25 % bupivacaineDrug
Also called 0.5% Marcaine
ultrasound guided transvers abdominis plane block
| Study group | Role | What they receive |
|---|---|---|
| 0.5% bupivacaine | Experimental | group 1 receiving TAP block with 0.25% bupivacaine 20 ml for each side of abdomen Bupivacaine is a local anaesthetic agent. transvers abdominis plane block with %0.5 Bustesin which is diluated with normal saline Receives: Drug: 0.25 % bupivacaine |
| dexmedetomidine added bupivacaine | Active comparator | group II receiving TAP block with 0.25% bupivacaine + 0.5 mcg/kg dexmedetomidine each side of abdomen Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid requirement
postoperative relief
Measured: 24 hr
Secondary outcomes (1)
postoperative nause and vomiting
patient relief
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: patients should have assurance to attend this study, money is the main problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda Yaman, Kırıkkale University
- Investigators
- Ferda Yaman, assist prof, Principal investigator, Kırıkkale University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331563
- Sponsor's protocol ID
- 20.10.2014/24/07
- Acronym
- USG
- Status last verified
- Jan 2015
- First submitted
- 1 Jan 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Effect of Dexmedetomidine for the Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Laparascopic Cholecystectomy: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02331563
- Acronym / sponsor ID
- USG / 20.10.2014/24/07
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: patients should have assurance to attend this study, money is the main problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 6 Jan 2015 (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.
A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D (n = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general anaesthesia. Total local anaesthetic volume was standardised with 20 ml each sides of the abdomen. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4, 5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.
Detailed description
Transversus abdominis plane (TAP) block has been shown to provide postoperative pain relief following various abdominal and inguinal surgeries. The aim of this randomised controlled trial was to assess the effect of transversus abdominis plane (TAP) blocks on opioid requirements and median hospitai stay, postoperative nause and vomitting in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% bupivacaine | Experimental | Drug: 0.25 % bupivacainegroup 1 receiving TAP block with 0.25% bupivacaine 20 ml for each side of abdomen Bupivacaine is a local anaesthetic agent. transvers abdominis plane block with %0.5 Bustesin which is diluated with normal saline |
| dexmedetomidine added bupivacaine | Active comparator | Drug: Dexmedetomidinegroup II receiving TAP block with 0.25% bupivacaine + 0.5 mcg/kg dexmedetomidine each side of abdomen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients undergoing laparascopic cholecystectomy
Key exclusion criteria (3 listed)
- Story of allergy to bupivacaine and dexmedetomidine
- The surgery preceeded to laparatomy
- Recent abdominal operation history
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 |
|---|---|---|
| DexmedetomidineAlso: precedexultrasound guided transvers abdominis plane block | Drug | dexmedetomidine added bupivacaine |
| 0.25 % bupivacaineAlso: 0.5% Marcaineultrasound guided transvers abdominis plane block | Drug | 0.5% bupivacaine |
Primary outcome
opioid requirement
Time frame: 24 hr
postoperative relief
1 secondary outcome
postoperative nause and vomiting
Time frame: 24 hrs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
Related trials for Postoperative Nausea and Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Ferda Yaman, assist prof principal investigator
Kırıkkale University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and 0.25 % bupivacaine in people with Postoperative Nausea and Vomiting, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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 3 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: withdrawn, as of the sponsor's last update on 4 Sep 2015. 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 Turkey (Türkiye). 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
opioid requirement (time frame: 24 hr). 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 4 Sep 2015.