Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04838379 |
| Other study ID # |
01210861577 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
January 2, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The current study aimed to assess the efficacy of Dexmedetomidine (DEX) and Dexamethasone as
an adjuvant to ultrasound guided TAP and RS block to prolongation of postoperative analgesia
and better pain control in children undergoing laparoscopic surgeries
Description:
Laparoscopic surgeries are one of the most frequently performed paediatric surgeries .
Although minimally invasive, this technique is still associated with a significant amount of
pain and anxiety in children . Indeed, children who are highly anxious prior to surgery tend
to have more postoperative pain, delayed hospital discharge, and higher incidence of
emergence delirium, sleep disturbances, and other mal-adaptive behaviour changes that can
last up to a few weeks following surgery . To improve analgesia and decrease postoperative
anxiety in children undergoing laparoscopic appendectomies multimodal approach for pain
control can be employed.
Over the past years, the concept of pain management has extended from simply decreasing pain
intensity to optimizing patient's condition. The goal is to decrease pain scores, stress
response that should be avoided in patients, particularly cardiac patients, together with a
decrease in analgesics-related adverse effects like nausea, vomiting, retention of urine and
over sedation. By achieving these goals, we can certainly facilitate patient recovery and
minimize the hospital stay. Improved pain control can be achieved by a combination of
different types of regional analgesia with systemic analgesics. The main contributor to pain
post abdominal operations is the pain from abdominal wall incision .
Many procedures were followed to decrease this intense postoperative pain such as, epidural
catheter analgesia, transversus abdominis plane (TAP) block, local wound infiltration,
Patient-Controlled Analgesia (PCA), peripheral nerve blocks, in addition to systemic
administration of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or opioids .
The transversus abdominis plane (TAP) block is a regional anesthetic technique that provides
analgesia to the parietal peritoneum as well as to the skin and muscles of the anterior
abdominal wall (9-10). Despite a relatively low risk of complications and a high success rate
using modern techniques, TAP block remains overwhelmingly underused. Although the technique
is technically straightforward, it has not been adopted in clinical practice .
Moreover, The Rectus Sheath Block (RSB) is one of these regional techniques that are suitable
for operations with a midline incision or laparoscopic surgery with the main incision at the
umbilical port. A previous study showed the analgesic efficacy of ultrasound guided rectus
sheath block for laparoscopic appendectomy compared to a control group injected with saline
instead of a local anesthetic Generally, in laparoscopic surgeries, the sites of port
incision are associated with considerable postoperative discomfort. Thus, we performed TAP
and RS block to ameliorate postoperative pain and improve patient outcomes. In addition to
the usefulness of traditional local anesthetics to provide analgesia during the course of the
postoperative period is restricted by their short duration of action .
Dexmedetomidine (DEX) and Dexamethasone has been shown as a valuable additives to local
anesthetics in neuraxial blocks and peripheral nerve blocks leading to prolongation of
postoperative analgesia and better pain control .
Dexmedetomidine (DEX) α-2 adrenergic receptor consists of three α-2 isoreceptors (α-2a, α-2b
and α-2c), which regulate the various pharmacodynamic effects of this drug . The α-2a
receptor seems to promote sedation and anxiolysis in the locus coeruleus, as well as to
generate bradycardia and peripheral vasodilation by stimulation of the cerebral vasomotor
center. The α-2b receptor prevents tremor, generates analgesia in the dorsal horns of the
spinal cord and determines peripheral vasoconstriction. The α-2c receptor modulates the
mental state .
Dexamethasone, a high-potency, long-acting glucocorticoid, has been shown to prolong
peripheral nerve blockade . Dexamethasone binds to glucocorticoid receptors and inhibits
potassium conductance, which decreases nociceptive C-fiber activity . Dexamethasone may also
extend the duration of analgesia via local vasoconstrictive and systemic anti-inflammatory
effects .
Thus, we performed TAP and RS block to ameliorate postoperative pain and improve patient
outcomes.
.
