Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Nausea and Vomiting, Postoperative Pain

Intervention / Treatment
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* Drug: Normal saline
* Drug: Ropivacaine at high concentration
* Drug: Ropivacaine and dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline<br>Before 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<br>* Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side<br>* Other names: 0. 9% Sodium Chloride Injection;|
| Experimental: Ropivacaine at high concentration<br>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 | Drug: Ropivacaine at high concentration<br>* 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<br>* Other names: Ropivacaine Hydrochloride Injection;|
| Experimental: Ropivacaine and dexamethasone<br>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 | Drug: Ropivacaine and dexamethasone<br>* 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<br>* Other names: Ropivacaine Hydrochloride Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting | The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV). | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative Sufentanyl Consumption during surgery | Each patient was administered sufentanil for analgesic during surgery | 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 | 48 hours after surgery | 
| Time of First Postoperative Analgesic Requiremen | First postoperative pain (NRS≥5) is initially controlled by titration of sufentany | 1hour after surgery | 
| Total Dose of First Postoperative Analgesic Requirement | First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl. | 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 | 48 hours after surgery | 
| Apfel score | The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV). | The 1 day before the surgery | 
| Time to ambulation | The obesity's time to ambulation after surge | 12 hours after surgery | 
| Mean time until passage of flatus | Gastrointestinal motility was evaluated by recording mean time until passage of flatus | 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. | 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. | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ropivacaine, Transversus abdominis plane block, opioid consumption, Dexamethasone