Analgesic Effect Between TAP Block and Continuous Wound Infusion in Abdominoplasty Surgery

Surgery of Abdominoplasty With Flank Liposuction Clinical Trial

Official title:

Comparative Analgesic Effect Between Continuous Wound Infusion and Transverse Abdominal Plan Block for Abdominoplasty Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01862354
• Other study ID #: 2013-00017214-14 2013/9
• Secondary ID: 2013-000172-14
• Status: Recruiting
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: University of Liege
• Contact: Jean-Pierre H Lecoq, MD, PhD
• Phone: 003243667180
• Email: jplecoq[@]chu.ulg.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized controlled study is to compare the postoperative analgesic effect of a continuous wound infusion of local anesthetics and a sole transverse abdominal plan (TAP) regional block in the surgery of Abdominoplasty Combined With Flank Liposuction. Local anesthetics products used are ropivacaine combined with clonidine. Similar amount of local anesthetics and clonidine are used.

Description:

In a first group, patients receive, after induction of anaesthesia and before surgery, a TAP block (transverse abdominal plan block) with 3mg/kg Ropivacaine 0.5% (maximum 200 mg) and 150 microg Clonidine.

In a second group, before skin closure, a multiholes catheter was inserted beyond the skin. 20 mg Ropivacaine 0.2% added with 150 microg Clonidine was injected as bolus dose through this catheter followed by a continuous infusion of Ropivacaine 0.2% 10ml per hour during the following 9 hours (total dose of 200 mgr).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for abdominoplasty combined with flank liposuction

Exclusion Criteria:

• Allergy to local anesthetics or clonidine

• Coagulation disorders

• History of chronic pain

• Alcohol or drugs dependance

• Refusal of the patients

Related Conditions & MeSH terms

• Surgery of Abdominoplasty With Flank Liposuction

Intervention

Procedure:
• Transverse abdominal plan block
Transverse abdominal plan block was performed after induction of anaesthesia and before surgery. 3 mg/kg of Ropivacaine 5mg/ml (maximum 200 mg) plus 150 microg of Clonidine were injected at the good place. The was realised with the aid of ultrasound
• Continuous wound infusion
In this group, a multihole catheter was surgically inserted vertically before skin closure. The catheter was primed with Ropivacaine 2 mg/ml 10 ml plus clonidine 150 microg before the end of anaesthesia. Continuous wound infusion was started at a rate of 10 ml per hour of Ropivacaine 2 mg/ml during the first 9 hours after the surgery.

Locations

Country	Name	City	State
Belgium	University of Liege, University Hospital	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total of peroperative propofol consumption (mg)		at the end of the anesthesia (average time around 180 minutes)
Other	Total of peroperative remifentanil consumption (mg)		at the end of the anesthesia (average time around 180 minutes)
Other	Volume of peroperative liquid infiltrated (ml)		at the end of the surgery (average time around 150 minutes)
Other	Volume of peroperative liquid suctioned (ml)		at the end of the surgery (average time around 150 minutes)
Other	Weight of skin resection (mg)		At the end of the surgery (average time around 150 minutes)
Other	Volume of surgical drainage (ml)		at day 1 and day 2
Primary	Pain score expressed on a visual analogue scale		at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Secondary	Piritramide consumption on Patient Controlled Analgesia (PCA) device		at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Secondary	Scale of nausea	Scale of nausea was defined as : 0 = No nausea - 1 = weak nausea - 2 = Moderate nausea - 3 = Important nausea	at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Secondary	Scale of sedation	Scale of sedation was defined as : 0 = Awake patient - 1 = Quiet and awake - 2 = Sleepy but arousable - 3 = Sleepy and not arousable	at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Secondary	Scale of patient's satisfaction	Scale of satisfaction was defined as : 1 = Very satisfied - 2 = Satisfied with no enthusiasm - 3 = Not satisfied	at day 2 postoperatively
Secondary	Number of patients with adverse events		daily during 48 hours postoperatively