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

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

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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.