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

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: TAP Block and Dexamethasone; Other: TAP Block and saline; Drug: TAP Block and Dexamethasone i.v.

• Registration Number: NCT02783144
• Lead Sponsor: San Salvatore Hospital of L'Aquila

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Study Start: 2017-06-28
• Primary Completion: 2019-03-13
• Status Verified: 2019-04
• Study Completion: 2019-04-15
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block and Dexamethasone	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.
TAP Block and Saline	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.
TAP Block and Dexamethasone i.v.	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.

Primary Outcome Measures

Name	Time	Method
Extension of analgesia, assessed in minutes after TAP block	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 Outcome Measures

Name	Time	Method
Rest pain, assessed with Visual Analog Scale	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).
Incident pain, assessed with Visual Analog Scale	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).

Trial Locations

Locations (1)

Emiliano Petrucci; 🇮🇹 L'Aquila, Italy