This study aims to test the hypothesis that ultrasound guided ESPB compared to patient controlled analgesia with Morphine, after a VATS lobectomy of wedge excision, reduces acute post-operative pain and opioid consumption. Our secondary aims are to…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
post-opereratieve pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The postoperative pain assessment is performed using NRS score (0 = no pain, 10
= most severe pain felt). Pain score at rest, while coughing and during
mobilisation will be recorded at 0, 2, 4, 8, 12 and 24hours postoperatively and
at day 2, two times a day at 08:00 and 20:00. Measured by a nurse who is
trained to take NRS scores.
Secondary outcome
• Total opioid consumption in milligrams after 24 hours and 48 hours.
• Length of stay at the recovery unit in minutes
• Patient satisfaction (NRS 0-10)
• Hospital length of stay in days
• Nausea, vomiting (yes / no) day 0 and 1 post-operatively requested in the
evening.
• Adverse events (pneumonia: diagnosed with a chest x-ray and positive sputum
culture)
Background summary
Post-operative pain management after minimal invasive video-assisted
thoracoscopic surgery (VATS) is previously managed with invasive techniques as
thoracic epidural anesthesia or paravertebral block. These techniques have rare
but serious risks. The less invasive intercostal block is often insufficient
and oral and parenteral opiods are frequently used. Opiates give side effects
such as nausea and sedation. The erector spinae plane block (ESPB) is an
alternative for the invasive pain management techniques and recudes opioid
consumption with fewer side effects.
In 2016 Forero et al. first described the ESPB, an interfascial plan block.
This novel regional anesthesia technique can be used for postoperative pain
management of the thoracoabdominal region. Recent emerging research showed ESPB
as a simple and safe analgesic technique for postoperative thoracic pain. The
ESPB is only described in case series in patients who have undergone a VATS
lobectomy or wedge excision, no adverse events such as hypotension, hematoma or
infection are mentioned.
Study objective
This study aims to test the hypothesis that ultrasound guided ESPB compared to
patient controlled analgesia with Morphine, after a VATS lobectomy of wedge
excision, reduces acute post-operative pain and opioid consumption. Our
secondary aims are to examine patient satisfaction, nausea and length of stay
at the recovery unit and hospitalization.
Study design
This study is a double blind, prospectively randomized, placebo controlled
study. The patients are divided in two groups. After routine monitoring,
general anesthesia was induced in both groups. After induction an ultrasound
guided erector spinea plane block will be performed. Once the needle tip is
placed whitin the interfacial plane below the erector spinae muscle 20cc
Levobupivacaine 0,5% will be injected in group 1 en 20cc NaCl 0,9% in group 2.
Paracetamol, Diclofenac and 0,1mg/kg Morphine is administered in both groups
after induction.
For postoperative analgesia, a 1000mg dose of Paracetamol every 6 hours and
50mg Diclofenac every 8 hours will be administered. All patients received as
rescue medication Morphine via a patient controlled analgesia device for the
first 24 hours.
The postoperative pain assessment is performed using NRS score (0 = no pain, 10
= most severe pain felt). Pain score at rest, while coughing and during
mobilisation will be recorded at 0, 2, 4, 8, 12 and 24hours postoperatively and
at day 2, two times a day at 08:00 and 20:00.
The postoperative opioid consumption side effects, such nauseau, vomiting and
sedation were also recorded.
Intervention
After induction an ultrasound guided erector spinea plane block at the T5
vertebra level will be performed. Once the 22 gauge 50mm needle tip is placed
whitin the interfacial plane below the erector spinae muscle 20cc
Levobupivacaine 0,5% will be injected in group 1 en 20cc NaCl 0,9% in group 2.
The anesthesiologist permorming the ESPB does not know whether Levobupivacaine
or NaCl is injected.
Levobupivacaine, the pure S (*) enantiomer of bupivacaine, emerged as a safer
alternative for regional anaesthesia than its racemic parent, with less
affinity and depressant effects on myocardial and central nervous vital centres
and a superior pharmacokinetic profile.
Study burden and risks
For the study the patient does not have to come to the hospital extra and there
will be no additional medical examination. We ask the patient after surgery to
enter the NRS pain score in the study diary and to indicate whether they are
nauseous and how satisfied they are with the pain relief. The side effects of
the local anesthetic, Levobupivacaine, are metallic taste, dizziness or
confusion. With our dosage we remain below the toxic dosage
Koekoeslaan 1
Nieuwegein 3435CM
NL
Koekoeslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing wedge resection or lobectomy through VATS
Exclusion criteria
contraindications for ESPB
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL70485.100.19 |