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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05286008
• Other study ID #: GWang022
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: March 2022
• Source: Tianjin Medical University General Hospital
• Contact: Guolin Wang, MD
• Phone: +8615822855556
• Email: wangguolinhad[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 15, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting	The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).	72 hours after surgery
Secondary	cumulative Sufentanyl Consumption during surgery	Each patient was administered sufentanil for analgesic during surgery	during surgery
Secondary	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
Secondary	Time of First Postoperative Analgesic Requiremen	First postoperative pain (NRS=5) is initially controlled by titration of sufentany	1hour after surgery
Secondary	Total Dose of First Postoperative Analgesic Requirement	First postoperative pain (NRS=5) is initially controlled by titration of sufentanyl.	1hour after surgery
Secondary	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
Secondary	Apfel score	The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).	The 1 day before the surgery
Secondary	Time to ambulation	The obesity's time to ambulation after surge	12 hours after surgery
Secondary	Mean time until passage of flatus	Gastrointestinal motility was evaluated by recording mean time until passage of flatus	72 hours after surgery
Secondary	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
Secondary	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