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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Normal saline; Drug: Ropivacaine at high concentration; Drug: Ropivacaine and dexamethasone

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guolin Wang, MD; Phone Number: +8615822855556; Email: wangguolinhad@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is scheduled to undergo Laparoscopic Bariatric Surgery
2. Subject's American Society of Anesthesiologists physical status is I-III.
3. BMI>35kg/m2
4. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

1. Subject has a diagnosis of renal or liver failure.
2. Subject has a diagnosis of mental illness
3. Subject is allergy and contraindication to Ropivacaine.
4. 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.
5. Subject has any contraindication for the use
6. Subject is pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 18, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Dexamethasone; Ropivacaine; opioid consumption; Transversus abdominis plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Ropivacaine
• Other Study ID Numbers: GWang022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No