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

S

San Salvatore Hospital of L'Aquila

Status and phase

Completed
Phase 3

Conditions

Postoperative Pain

Treatments

Procedure: TAP Block and Dexamethasone
Drug: TAP Block and Dexamethasone i.v.
Other: TAP Block and saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02783144
0024575/16

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 3 patient groups, including a placebo group

TAP Block and Dexamethasone
Experimental group
Description:
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.
Treatment:
Procedure: TAP Block and Dexamethasone
TAP Block and Saline
Placebo Comparator group
Description:
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.
Treatment:
Other: TAP Block and saline
TAP Block and Dexamethasone i.v.
Active Comparator group
Description:
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.
Treatment:
Drug: TAP Block and Dexamethasone i.v.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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