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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783144
• Other study ID #: 0024575/16
• Status: Completed
• Phase: Phase 3
• Start date: June 28, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2019
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 15, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• TAP 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

Other:
• TAP 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

Drug:
• TAP 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

Locations

Country	Name	City	State
Italy	Emiliano Petrucci	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
San Salvatore Hospital of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours after surgery
Secondary	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).	24 hours after surgery
Secondary	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).	24 hours after surgery