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

Sponsor
Tianjin Medical University General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05286008
Collaborator
(none)
90
3
6.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Normal saline
  • Drug: Ropivacaine at high concentration
  • Drug: Ropivacaine and dexamethasone
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Mar 18, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 15, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. cumulative Sufentanyl Consumption during surgery [during surgery]

      Each patient was administered sufentanil for analgesic during surgery

    2. 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

    3. Time of First Postoperative Analgesic Requiremen [1hour after surgery]

      First postoperative pain (NRS≥5) is initially controlled by titration of sufentany

    4. Total Dose of First Postoperative Analgesic Requirement [1hour after surgery]

      First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.

    5. 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

    6. Apfel score [The 1 day before the surgery]

      The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).

    7. Time to ambulation [12 hours after surgery]

      The obesity's time to ambulation after surge

    8. Mean time until passage of flatus [72 hours after surgery]

      Gastrointestinal motility was evaluated by recording mean time until passage of flatus

    9. 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.

    10. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tianjin Medical University General Hospital

    Investigators

    • Study Director: Guolin Wang, MD, Tianjin Medical University General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guolin Wang, Professor, Tianjin Medical University General Hospital
    ClinicalTrials.gov Identifier:
    NCT05286008
    Other Study ID Numbers:
    • GWang022
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guolin Wang, Professor, Tianjin Medical University General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2022