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

Not Applicable

• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting
• Interventions: Drug: Ropivacaine at high concentration; Drug: Ropivacaine and dexamethasone; Drug: Normal saline

• Registration Number: NCT05286008
• Lead Sponsor: Tianjin Medical University General Hospital

Brief 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

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 Timeline

• Study First Submitted: 2022-01-24
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Study Start: 2022-03-18
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine at high concentration	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	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
Normal Saline	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.

Primary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	72 hours after surgery	The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).

Secondary Outcome Measures

Name	Time	Method
cumulative Sufentanyl Consumption during surgery	during surgery	Each patient was administered sufentanil for analgesic during surgery
Mean time until passage of flatus	72 hours after surgery	Gastrointestinal motility was evaluated by recording mean time until passage of flatus
Diffusion area of local anesthetics after transversus abdominis plane block	30 minutes after transversus abdominis plane block	Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance.
Time of First Postoperative Analgesic Requiremen	1hour after surgery	First postoperative pain (NRS≥5) is initially controlled by titration of sufentany
Apfel score	The 1 day before the surgery	The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
The incidence of Side Effects	48 hours after surgery	The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 48 hours postoperatively
Total Dose of First Postoperative Analgesic Requirement	1hour after surgery	First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
cumulative Sufentanyl Consumption after surgery	48 hours 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
Time to ambulation	12 hours after surgery	The obesity's time to ambulation after surge
Normalized Area of Hyperalgesia Around the Incision	48 hours after surgery	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.