Nausea and VomitingPhase 2NCT05016180
Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery
A Phase 2 study testing Ropivacaine in people with Nausea and Vomiting and Laparoscopic Bariatric Surgery, run by Tianjin Medical University General Hospital at 2 sites in China.
Trial summary
Purpose: To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nausea and Vomiting, Laparoscopic Bariatric Surgery
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 25 Sep 2020to 25 Dec 2021
- Phase
- Phase 2
- 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
- Subject is scheduled to undergo Laparoscopic Bariatric Surgery
- Subject's American Society of Anesthesiologists physical status is I-III.
- BMI>35kg/m2
- The subject's parent/legally authorized guardian has given written informed consent to participate
Who cannot join
- Subject has a diagnosis of renal or liver failure.
- Subject has a diagnosis of mental illness
- Subject is allergy and contraindication to Ropivacaine.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- Subject is pregnant or breast-feeding.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Guolin Wang, M.D., Ph. D., 86-22-60362606, wang_guolin@hotmail.com
Guolin Wang, M.D PHD
- Recruiting
Zhen Jia
Tianjin, Tianjin Municipality
Jia Zhen, MD, 13002211205, 1464322162@qq.com
About this study
Official title: Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Nausea and Vomiting and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial
Purpose:
To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia
Read the detailed description
Poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with ropivacaine in Laparoscopic Bariatric Surgery
- Being tested
- Ropivacaine
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Before the induction of anesthesia, ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side Receives: Drug: Ropivacaine |
| Ropivacaine | Experimental | Before the induction of anesthesia, Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
Postoperative nausea and vomiting
Measured: 72 hours after surgery
Secondary outcomes (4)
Cumulative Sufentanyl Consumption
Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively
Measured: 24 hours after surgery
Time of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl
Measured: 1 hour after surgery
Occurrence of Side Effects
Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
Measured: 24 hours after surgery
Total Dose of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl.
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start25 Sep 2020
- Primary completion26 Nov 2021 (estimated)
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, MD, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016180
- Sponsor's protocol ID
- IRB2020-YX-083-01
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Nausea and Vomiting and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT05016180
- Acronym / sponsor ID
- IRB2020-YX-083-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 26 Nov 2021 (estimated)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 23 Aug 2021 (actual)
- 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.
Purpose:
To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia
Detailed description
Poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with ropivacaine in Laparoscopic Bariatric Surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: RopivacaineBefore the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side |
| Ropivacaine | Experimental | Drug: RopivacaineBefore the induction of anesthesia, Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is scheduled to undergo Laparoscopic Bariatric Surgery
- Subject's American Society of Anesthesiologists physical status is I-III.
- BMI>35kg/m2
- The subject's parent/legally authorized guardian has given written informed consent to participate
Key exclusion criteria (6 listed)
- Subject has a diagnosis of renal or liver failure.
- Subject has a diagnosis of mental illness
- Subject is allergy and contraindication to Ropivacaine.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
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 |
|---|---|---|
| RopivacaineBefore the induction of anesthesia, ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug | Normal Saline, Ropivacaine |
Primary outcome
Postoperative nausea and vomiting
Time frame: 72 hours after surgery
Postoperative nausea and vomiting
4 secondary outcomes
Cumulative Sufentanyl Consumption
Time frame: 24 hours after surgery
Time of First Postoperative Analgesic Requirement
Time frame: 1 hour after surgery
Occurrence of Side Effects
Time frame: 24 hours after surgery
Total Dose of First Postoperative Analgesic Requirement
Time frame: 1 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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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.
Guolin Wang, MD study director
Tianjin Medical University General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine in people with Nausea and Vomiting and Laparoscopic Bariatric Surgery, run by Tianjin Medical University General Hospital at 2 sites in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Jia, MD (13002211205, 1464322162@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting (time frame: 72 hours after surgery). 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 23 Aug 2021.