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

Phase 2

• Conditions: Laparoscopic Bariatric Surgery; Nausea and Vomiting
• Interventions: Drug: Ropivacaine

• Registration Number: NCT05016180
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

Purpose:

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, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with ropivacaine in Laparoscopic Bariatric Surgery

Study Timeline

• Study Start: 2020-09-25
• Study First Submitted: 2021-06-30
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Study First Posted: 2021-08-23
• Last Update Posted: 2021-08-23
• Primary Completion: 2021-11-26
• Study Completion: 2021-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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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 of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine	Before the induction of anesthesia, Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Normal Saline	Ropivacaine	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	Postoperative nausea and vomiting

Secondary Outcome Measures

Name	Time	Method
Cumulative Sufentanyl Consumption	24 hours after surgery	Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively
Time of First Postoperative Analgesic Requirement	1 hour after surgery	First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl
Occurrence of Side Effects	24 hours after surgery	Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
Total Dose of First Postoperative Analgesic Requirement	1 hour after surgery	First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl.

Trial Locations

Locations (2)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Zhen Jia; 🇨🇳 Tianjin, Tianjin, China