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Completed

NCT Number: NCT02783144

Dexamethasone Added in Ultrasound-guided Transversus Abdominis Plain Block for Postoperative Analgesia

Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.

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Key information

Conditions

Postoperative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emiliano Petrucci

L’Aquila, 67100, Italy

About this study

In the ultrasound-guided TAP-Block with Dexamethasone group, dexamethasone is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with saline group, saline is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block , after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with intravenously dexamethasone group, dexamethasone is intravenously injected , after Laparoscopic Cholecystectomy. After surgery the extension of postoperative analgesia, incident and rest pain were evaluate in each group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with ASA score I and II
  • age 18 years

Exclusion criteria

  • Allergy to local anesthetics
  • Allergy to general anesthetics
  • Allergy or intolerance to acetaminophen
  • Severe renal impairment
  • Severe hepatic impairment
  • Congestive heart failure
  • Coagulation disorders
  • hypoprotidemia
  • Diabetes mellitus History
  • Age greater than 70 years
  • Age below 18 years
  • ASA Physical than 3 Status
  • Lack of informed consent
  • Patients unable to discernment
  • Intolerance to opiates
  • Peptic Ulcer
  • Abuse of alcohol and / or drugs

Treatment and study plan

TAP Block and Dexamethasone

Procedure

After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is added to levopubivacaine

Other names: TAP-Block under ultrasound guidance and dexamethasone

TAP Block and saline

Other

After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and saline is added to levopubivacaine

Other names: TAP-Block under ultrasound guidance and saline

TAP Block and Dexamethasone i.v.

Drug

After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is injected intravenously

Other names: TAP-Block under ultrasound guidance and i.v. dexamethasone

Primary outcomes

  1. Extension of analgesia, assessed in minutes after TAP block

    Time frame: 24 hours after surgery

    After surgery, the extension of analgesia is evaluated in minutes after TAP Block, in the first 24 hours, from operating theatre discharge.

Secondary outcomes

  1. Rest pain, assessed with Visual Analog Scale

    Time frame: 24 hours after surgery

    Rest pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain).

  2. Incident pain, assessed with Visual Analog Scale

    Time frame: 24 hours after surgery

    Incident pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain).

Sponsors and collaborators

Lead sponsor

San Salvatore Hospital of L'Aquila

Other

Registry information

Official study title

Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 26, 2016
Registry last updated
Apr 18, 2019

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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