Post-operative Pain Clinical Trial
Official title:
Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS) Lobectomy or Wedge Resections - a Pilot Randomized Control Trial
This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal nerve block plus PCA as post-operative pain control for patients having video-assisted thorascopic surgeries.
Video assisted thoracoscopic surgery (VATS) has become an increasingly popular technique in
thoracic surgery with improvement in technology. It provides significant advantages over open
thoracotomy procedures including reduced acute pain, reduced mortality, improved
post-operative pulmonary function, and shorter hospitalization stays. Nevertheless, there is
still considerable amount of post-operative acute pain with VATS lobectomies. Controlling
post-operative pain is crucial because increased acute pain has been associated with the
development of chronic pain.
Many patients receive either thoracic epidural (TEA) or paravertebral blocks (PVB) to treat
post-operative pain in thoracotomy procedures as these techniques remain the gold standard.
In contrast to thoracotomy procedures, it is unclear which is the best approach to analgesia
is in VATS. A few studies have found no benefit in pain scores, patient satisfaction,
pulmonary function, and incidence of side effects when comparing TEA with opioid patient
controlled analgesia in VATS. Other studies have found minimal benefit in pain scores with
TEA. The PVB has been used as alternative to TEA. One prospective observational study using
PVB and continuous intercostal catheter demonstrated lower pain scores in VATS lobectomy. A
randomized control trial (RCT) comparing PVB with wound infiltration in VATS lobectomy showed
lower pain scores, lower morphine consumption, and higher patient satisfaction. However, both
TEA and PVB have potential serious side-effects and complications. Complications of TEA
include severe hypotension, epidural abscess, epidural hematomas and spinal cord injury. PVB
have less incidence of hypotension but may involve risks like pneumothorax, pleural and
vascular puncture, and higher systemic absorption of local anesthetics. PVB is also
technically challenging and its spread is not reliable likely due to the presence of the
endothoracic fasica. In addition, placement of both TEA and PVB require appropriate
discontinuation of anticoagulants. Intercostal nerve blocks have been used as an analgesic
alternative to TEA and PVB. One RCT found patients who had received intercostal blocks
undergoing bilateral VATS for hyperhidrosis had lower pain scores in the post-anesthesia
recovery unit (PACU). A combined retrospective and prospective study examined the analgesic
effect and duration of intercostal blocks in patients undergoing VATS. The authors found that
intercostal blocks decreased morphine consumption in the first 24 hours and the analgesic
effect of the block lasted approximately 16 hours. Intercostal blocks appear to have some
analgesic effect in the immediate post-operative period but are short-lived unless a catheter
is placed. The standard practice for post-operative pain management for VATS lobectomy at St.
Joseph's hospital consists of intercostal blocks performed by the thoracic surgeons at the
end of surgery in combination with patient-controlled analgesia (PCA).
A novel regional technique called the Erector Spinae Plane (ESP) block has been recently
described. This interfascial block involves ultrasound guided injection of local anesthetics
posterior to the erector spinae muscle and superficial to transverse process of thoracic
vertebrae at appropriate level. The ESP block appears to target the dorsal and ventral rami
of the spinal nerves as they leave the intervertebral foramen. Cadaveric examination of ESP
block showed extensive cranial-caudal spread of the block, approximately four dermatomes
above and below the site of injection. The ESP block has been successfully applied in
multiple clinical settings. For example, several patients suffering from chronic thoracic
neuropathic pain achieved significant analgesia after receiving ESP blocks. ESP blocks have
also been used as a rescue analgesia for a patient who failed a TEA after thoracotomy. Other
applications include ventral hernia repair in abdominal surgery. The simplicity and safety of
the ESP block has been proposed as its main advantages. Because it is a superficial
interfascial plane block, it is distant from both the spinal cord and pleura. The ESP block
is technically an easy to perform under ultrasound guidance due to its superficial location.
There is also theoretically less possibility of needle related complications as the
transverse process acts as a backstop for needle advancement. A catheter can be placed easily
during the ESP block allowing continuous infusion and prolonged analgesia.
Given the importance of providing adequate analgesia in VATS lobectomy and wedge resections
and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic
technique, the investigators are proposing a prospective observational study to examine the
analgesic efficacy of the ESP block in VATS lobectomy or wedge resections as a potential
alternative to TEA, PVB and intercostal blocks. The investigators are hoping the results of
this study will provide framework for future larger comparative studies.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02489526 -
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery
|
Phase 2 | |
Completed |
NCT05635916 -
Trial of Liposomal Bupivacaine for TKA
|
Phase 4 | |
Terminated |
NCT05146453 -
Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology
|
Phase 4 | |
Recruiting |
NCT06028126 -
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
|
N/A | |
Not yet recruiting |
NCT03591172 -
Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization
|
N/A | |
Completed |
NCT01667445 -
Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT01686802 -
Post-operative Oral Morphine Versus Ibuprofen
|
Phase 2 | |
Completed |
NCT01444924 -
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
|
Phase 2 | |
Completed |
NCT00830089 -
Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery
|
N/A | |
Completed |
NCT00968955 -
Effect of Local Infiltration Analgesia in Total Hip Arthroplasty
|
Phase 4 | |
Completed |
NCT00847093 -
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
|
Phase 4 | |
Terminated |
NCT00875862 -
Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks
|
Phase 4 | |
Completed |
NCT00390312 -
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
|
Phase 2 | |
Recruiting |
NCT05278494 -
Dextromethorphan for Treatment of Postoperative Pain
|
N/A | |
Recruiting |
NCT05973045 -
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
|
N/A | |
Not yet recruiting |
NCT04999670 -
Fascial Closure and Post-caesarean Pain
|
N/A | |
Enrolling by invitation |
NCT04346407 -
Dronabinol for Post-operative Pain After Lumbar Fusion
|
Phase 4 | |
Completed |
NCT03635515 -
Occurrence of Post-op Pain Following Gentlewave
|
N/A | |
Terminated |
NCT03201809 -
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
|
N/A | |
Completed |
NCT03254056 -
Fascial Closure Techniques Post-Operative Pain Laparoscopy
|
N/A |