Postoperative Nausea and VomitingNCT05286008
Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery
A study testing Normal saline, Ropivacaine at high concentration and Ropivacaine and dexamethasone in people with Postoperative Nausea and Vomiting and Postoperative Pain, run by Tianjin Medical University General Hospital.
Trial summary
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 20 to 60 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Postoperative Pain
- What is being tested?
- Normal saline, Ropivacaine at high concentration and Ropivacaine and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2022to 15 Oct 2022
- Phase
- Interventional
- 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 20 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
- Subject is pregnant or breast-feeding.
Trial locations and contacts
No sites are listed yet.
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
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, investigators will evaluate the efficacy of ultrasound-guided transversus abdominis plane(USG- TAP) block with ropivacaine in Laparoscopic Bariatric Surgery.
- Being tested
- Normal saline, Ropivacaine at high concentration, Ropivacaine and dexamethasone
- Keywords
- Ropivacaine, Transversus abdominis plane block, opioid consumption, Dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called 0. 9% Sodium Chloride Injection
Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Ropivacaine at high concentrationDrug
Also called Ropivacaine Hydrochloride Injection
Before the induction of anesthesia,0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Ropivacaine and dexamethasoneDrug
Also called Ropivacaine Hydrochloride Injection
Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are 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: Normal saline |
| Ropivacaine at high concentration | Experimental | Before the induction of anesthesia, 0.375% Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side Receives: Drug: Ropivacaine at high concentration |
| Ropivacaine and dexamethasone | Experimental | Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side Receives: Drug: Ropivacaine and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
Measured: 72 hours after surgery
Secondary outcomes (10)
cumulative Sufentanyl Consumption during surgery
Each patient was administered sufentanil for analgesic during surgery
Measured: during surgery
cumulative Sufentanyl Consumption after surgery
Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a totalvolume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperative
Measured: 48 hours after surgery
Time of First Postoperative Analgesic Requiremen
First postoperative pain (NRS≥5) is initially controlled by titration of sufentany
Measured: 1hour after surgery
Total Dose of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Measured: 1hour after surgery
The incidence of Side Effects
The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 48 hours postoperatively
Measured: 48 hours after surgery
Apfel score
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
Measured: The 1 day before the surgery
Time to ambulation
The obesity's time to ambulation after surge
Measured: 12 hours after surgery
Mean time until passage of flatus
Gastrointestinal motility was evaluated by recording mean time until passage of flatus
Measured: 72 hours after surgery
Diffusion area of local anesthetics after transversus abdominis plane block
Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance.
Measured: 30 minutes after transversus abdominis plane block
Normalized Area of Hyperalgesia Around the Incision
The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper'feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start18 Mar 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT05286008
- Sponsor's protocol ID
- GWang022
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. 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
- NCT05286008
- Acronym / sponsor ID
- GWang022
- Keywords
- Ropivacaine, Transversus abdominis plane block, opioid consumption, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 18 Mar 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 18 Mar 2022 (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.
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, investigators 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Normal salineBefore the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. |
| Ropivacaine at high concentration | Experimental | Drug: Ropivacaine at high concentrationBefore the induction of anesthesia, 0.375% Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side |
| Ropivacaine and dexamethasone | Experimental | Drug: Ropivacaine and dexamethasoneBefore the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side |
Who may qualify
- Ages
- 20 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
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 |
|---|---|---|
| Normal salineAlso: 0. 9% Sodium Chloride InjectionBefore the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug | Normal Saline |
| Ropivacaine at high concentrationAlso: Ropivacaine Hydrochloride InjectionBefore the induction of anesthesia,0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug | Ropivacaine at high concentration |
| Ropivacaine and dexamethasoneAlso: Ropivacaine Hydrochloride InjectionBefore the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug | Ropivacaine and dexamethasone |
Primary outcome
Postoperative nausea and vomiting
Time frame: 72 hours after surgery
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
10 secondary outcomes
cumulative Sufentanyl Consumption during surgery
Time frame: during surgery
cumulative Sufentanyl Consumption after surgery
Time frame: 48 hours after surgery
Time of First Postoperative Analgesic Requiremen
Time frame: 1hour after surgery
Total Dose of First Postoperative Analgesic Requirement
Time frame: 1hour after surgery
The incidence of Side Effects
Time frame: 48 hours after surgery
Apfel score
Time frame: The 1 day before the surgery
Time to ambulation
Time frame: 12 hours after surgery
Mean time until passage of flatus
Time frame: 72 hours after surgery
Diffusion area of local anesthetics after transversus abdominis plane block
Time frame: 30 minutes after transversus abdominis plane block
Normalized Area of Hyperalgesia Around the Incision
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- 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.
Guolin Wang, MD study director
Tianjin Medical University General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline, Ropivacaine at high concentration and Ropivacaine and dexamethasone in people with Postoperative Nausea and Vomiting and Postoperative Pain, run by Tianjin Medical University General Hospital.
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 18 Mar 2022. 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.
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 Guolin Wang, MD (+8615822855556, wangguolinhad@hotmail.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 18 Mar 2022.