Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT02505204 |
| Other study ID # |
07/09/2015 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2015 |
| Est. completion date |
April 2023 |
Study information
| Verified date |
January 2022 |
| Source |
Makassed General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Paravertebral block (PVB) combined with light intravenous sedation was associated with a
short hospital stay, less post-operative nausea and vomiting and reduced analgesic
consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness
of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with
versus without clonidine in elderly patients.
Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the
sealed envelope technique. Group one will receive PVB with clonidine while group 2 will
receive PVB with placebo.
Description:
Introduction
Paravertebral block (PVB) showed to be successful in both children and adults. It has been
reported to be an excellent pain reliever and it reduces post-operative nausea and vomiting,
in patients undergoing breast surgery. PVB has proven to be very useful as a regional
anesthetic technique when it comes to surgeries involving lumbar and thoracic dermatome. It
was shown that the PVB combined with light intravenous sedation was associated with a short
hospital stay, less post-operative nausea and vomiting (PONV) and reduced analgesic
consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness
of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with
versus without clonidine in elderly patients.
Objectives:
The primary objective of this study is to compare the hemodynamic stability in a ventral
hernia repair using paravertebral block with clonidine versus the PVB without clonidine.
The secondary objectives include a comparison of PONV and postoperative analgesic
consumption.
Materials and Methods
Study design and sampling This is a prospective study with a randomized double- blinded
design that will be conducted between August 2015 and August 2016.
Patients scheduled for ventral hernia repair whose age is 65 years and older with American
Society of Anesthesiologists (ASA) greater or equal to 2 will be included. Exclusion criteria
comprised history of allergic reactions to local anesthetics, bleeding diatheses and spinal
abnormality.
Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the
sealed envelope technique. Group one will receive PVB with clonidine while group 2 will
receive PVB with placebo.
Anesthetic techniques Since this trial is double-blinded, a specialized nurse will prepare
the syringes for each patient.
Paravertebral nerve block techniques Bilateral nerve-stimulator PVB will be performed at the
levels of T9-T10 or T9-T11 according to the type of ventral hernia and the planned incision
type. The patient will be anesthetized in the lateral decubitus position. Supplemental oxygen
will be given by facemask and regular anesthetic monitors will be attached.
Each local anesthetic mixture will contain:
For group 1, the syringes will contain: lidocaine 2% 6 mL, lidocaine 2% 6 mL with epinephrine
5µg.mL-1, bupivacaine 0.5% 5 mL, fentanyl 1 mL (50µg) and clonidine 2 mL.
As for the group 2, the same anesthetic mixture will be administrated however the clonidine
will be substituted with 2 mL saline.
Data collection
Demographic data, ASA score, type and duration of surgery will be recorded. Haemodynamics
will be registered such as the mean arterial blood pressure, heart rate and oxygen
saturation, preoperatively (baseline), intra-operatively (incision of skin, dissection of
hernia, traction over the sac and closure of incision) and postoperatively.
As for postoperative analgesia consumption, patients with a VAS score between three and four
are given Tramadol Hydrochloride 50-100 mg every 4- 6 hours. If the VAS score is greater or
equal to five, patients receive 1 mg/kg Dolosal.
Post-operative nausea and vomiting will be recorded in the recovery room and in the regular
ward. Pain assessment will be taken from patients by a verbal statement using Numeric Rating
Scale.
