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CompletedNCT02783144Updated Apr 18, 2019

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

A Phase 3 interventional study of TAP Block and Dexamethasone and TAP Block and saline in Postoperative Pain, sponsored by San Salvatore Hospital of L'Aquila. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by San Salvatore Hospital of L'Aquila · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Postoperative Pain

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Keywords

  • Analgesia
  • Dexamethasone
  • Levobupivacaine
  • Ultrasound-guided
  • Tranversus Abdominis
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 120 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

San Salvatore Hospital of L'Aquila is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    TAP Block and Dexamethasone

    After general anesthesia and before the beginning of surgery, 4 mg of Dexamethasone are added to 20 ml of 0,375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block.

    Procedure: TAP Block and Dexamethasone

  • Placebo comparator
    TAP Block and Saline

    After general anesthesia and before the beginning of surgery, 2 ml of saline are added to 20 ml of 0.375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block.

    Other: TAP Block and saline

  • Active comparator
    TAP Block and Dexamethasone i.v.

    After general anesthesia and before the beginning of surgery, 20 ml of 0,375% Levobupivacaine are used in Ultrasound-guided Tranversus Abdominis Plain Block. In this group 4 mg of dexamethasone are injected intravenously.

    Drug: TAP Block and Dexamethasone i.v.

Interventions

  • ProcedureTAP Block and Dexamethasone

    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

    Also known as: TAP-Block under ultrasound guidance and dexamethasone

  • OtherTAP Block and saline

    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

    Also known as: TAP-Block under ultrasound guidance and saline

  • DrugTAP Block and Dexamethasone i.v.

    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

    Also known as: TAP-Block under ultrasound guidance and i.v. dexamethasone

06

What researchers measure

Primary outcomes

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

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

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Rest pain, assessed with Visual Analog Scale

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

    Time frame: 24 hours after surgery

  2. Incident pain, assessed with Visual Analog Scale

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

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Emiliano Petrucci
    L'Aquila, 67100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02783144
Lead sponsor
San Salvatore Hospital of L'Aquila
Responsible party
Emiliano Petrucci (Doctor, San Salvatore Hospital of L'Aquila) — Principal investigator
First posted
May 26, 2016
Start date
Jun 28, 2017
Primary completion
Mar 13, 2019
Completion
Apr 15, 2019
Last update
Apr 18, 2019

Study contacts

Emiliano Petrucci
principal investigator · San Salvatore Academic Hospital of L'Aquila

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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