Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05725083 |
| Other study ID # |
Epidural vs ESPB in PCNL |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 11, 2024 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Assiut University |
| Contact |
keroles Heshmat Ghaly, MBBS |
| Phone |
01271655519 |
| Email |
kero.heshoo[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
compare the efficacy of Lower Thoracic Epidural with Erector spinae plane block (ESPB) for
post-operative analgesia after Percutaneous Nephrolithotomy with a hypothesis that both Lower
Thoracic Epidural and Erector spinae plane block are effective in providing post-operative
analgesia.
Description:
Percutaneous nephrolithotomy (PCNL) is the treatment of choice for patients with multiple or
complex kidney or upper urinary tract stones, which necessitates the meticulous
multi-modality analgesia due to mild to moderate pain originated from renal capsule dilation
or nephrostomy-tube-related stress during the first 24 h after operation.
The main sources of the acute pain after PCNL are visceral pain originating from the kidneys
and ureters, and somatic pain from the site incision. Renal pain is conducted through T10-L1
spinal nerves while ureter pain is conducted through T10-L2. Moreover, cutaneous innervation
of the site of the incision is predominantly supplied by T10-T11 (T8-T12) because the
incision site and tract for PCNL is usually used in the tenth to eleventh intercostal space,
or in the subcostal area Blockade of both somatic and visceral nerves that innervate skin,
muscle, kidneys, and ureters is required for the achievement of adequate analgesia after
PCNL. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient
analgesia during PCNL. This can be achieved by several regional techniques such as Lower
Thoracic Epidural , Thoracic paravertebral block, Transversus abdominis block, Erector spinae
block, and peri-tubal local anaesthetic infiltration .
PCNL surgery also has an increased risk for postoperative pulmonary complications because the
procedure is performed near the diaphragm, especially, when approached through the upper pole
of the kidney which increases the possibility of pleural and lung injuries. with poor control
of the postoperative pain, this can result in decreased inspiratory and vital capacities and
increase the incidence of lung atelectasis and postoperative hypoxemia. Multimodal analgesia
techniques are utilized broadly to manage postoperative pain. The concept of multimodal
analgesia implies not only providing analgesic drugs, but also performing nerve blocks with
local anaesthetics.
Since Forrero et al. first described the Erector Spinae Plane Block (ESPB), the indications
and clinical use of the block for different surgical interventions have been growing .
Although, ESPB is an interfascial plane block, anatomical studies support the idea that some
of its clinical benefit may derive from spread to the paravertebral and epidural space.
Regional anesthesia may reduce the rate of chronic pain after surgery . Thoracic epidural
blockade (TEB) using local anesthetic agents has been widely regarded as the gold standard
for analgesia and reduction of associated complications following surgery.
Epidural analgesia was first accomplished by blockage with local anesthetics, and bupivacaine
has been called the local anesthetic of choice for epidural infusion.. Epidural local
anesthetics have been administered by continuous infusion in an attempt to minimize side
effects , Nevertheless, hypotension as well as motor block , numbness , nausea and urinary
retention have occurred.
Good analgesia from an epidural block can result in relieving postoperative pain , early
extubation, better ventilatory mechanics and gas exchange and reduced rates of lung collapse,
pneumonia and pain . However, the technique requires highly trained medical staff not only
for insertion and removal of the epidural catheter but also for the management of the
continuous infusion of pain medication. The risks associated with insertion of the epidural
include accidental dural puncture, inadvertent high block, local anesthetic toxicity and
total spinal anesthesia (inadvertent spinal injection of an epidural dose of local
anesthetic), nerve injury, epidural hematoma and abscess are rare but serious complications.
Epidural is not a suitable technique for all patients and is contraindicated in patients with
local infection, previous spinal surgery, disorders of blood clotting and in those taking
anti-coagulant and anti-platelet therapy .
Thus, in the current study the investigators aim to compare the post-operative analgesic
effect of Lower Thoracic Epidural with that of ESPB after Percutaneous Nephrolithotomy.
