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OpenTrials
Completed

NCT Number: NCT05447429

The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure.

Sleeve gastrectomy is the most performed bariatric procedure worldwide. Postoperative pain management is a challenging issue. In this trial, the investigators aimed to explore the effects of laparoscopic guided transversus abdominis plane (TAP) block on postoperative pain management in patient those were performed laparoscopic sleeve gastrectomy.

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Key information

Conditions

Obesity, Morbid Body Weight Nausea Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun Research and Training Hospital

Samsun, Turkey (Türkiye)

About this study

TAP block is a regional anesthesia technique which could be performed easily especially by laparoscopy and are used in various surgical procedures. In that technique, blockade of the plane between internal oblique muscle and transversus abdominis muscle is performed by infiltration of local anesthesics drugs. Therefore , reduction of postoperative pain could be lead to decrease in postoperative complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients between 18-65
  • undergo Laparoscopic sleeve gastrectomy

Exclusion criteria

  • Bupivacaine allergy
  • having chronic pain or taking pain management
  • ASA ( The American Society of Anesthesiologists Physical Classification System) Class 4 or
  • Patients who were performed additional procedures including cholecystectomy, hiatal hernia repair or abdominal hernia repair

Treatment and study plan

transversus abdominis plane block

Procedure

TAP block will be performed by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

Placebo

Drug

20 ml saline solution will be injected by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

Primary outcomes

  1. visual analogue scale (VAS) scores

    Time frame: 24th ours

    VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10

  2. postoperative analgesia doses

    Time frame: within 24 hours postoperatively

    totally consumed analgesics

Secondary outcomes

  1. Nausea and vomiting score

    Time frame: within 24 hours postoperatively

    PONV (Postoperative nausea and vomiting) score calculated with PONV scale: score 0: no nausea or vomiting, score 1:mild nausea, not requesting medication, score 2: moderate nausea requesting medication, score 3: severe nausea and/or vomiting minimum:0 maximum:3

  2. first mobilization and flatus time

    Time frame: within 24 hours postoperatively

    first mobilization and flatus time

  3. time of first opioid administration

    Time frame: within 24 hours postoperatively

    time of first opioid administration

Other outcomes

  1. operation time

    Time frame: time from first incision to last suture

    operation time

Sponsors and collaborators

Lead sponsor

Samsun Education and Research Hospital

Other

Registry information

Official study title

The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure: A Randomized Single Blinded Placebo Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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