Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05769881 |
Other study ID # |
1221 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 25, 2023 |
Est. completion date |
December 13, 2023 |
Study information
Verified date |
December 2023 |
Source |
Sisli Hamidiye Etfal Training and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Laparoscopic cholecystectomy surgery is an intra-abdominal surgery that is frequently used in
the treatment of gallbladder-related pathologies. Compared to open surgery, the cost, the
risk of bleeding, the risk of surgical site infection are lower, the need for hospitalization
is shorter, and the recovery is rapid. Adequate pain relief is very important after
laparoscopic cholecystectomy. Inadequate analgesia in post-operative period has been
associated with pain-related cognitive dysfunction, atelectasis, thromboembolic events,
increased surgery-related stress response, prolonged hospital stay, and chronic pain in
patients. Acetaminophen, non-steroidal anti-inflammatory drugs, opioid analgesics,
intraperitoneal washing, local anesthesia infiltration and various regional anesthesia
techniques can be used for appropriate analgesia. Studies have shown that subcostal
transversus abdominis block has good analgesic efficacy in laparoscopic cholecystectomy
surgeries. In the perioperative and postoperative period, afferent nerve signals in the
surgical incision area stimulate the hypothalamus, causing the release of CRH, arginine
vasopressin, and cortisol depending on the size of the surgical procedure. Providing patients
with appropriate postoperative analgesia reduces the release of the stress hormones cortisol
and prolactin.
In this study, the investigators are aiming to compare the post-operative analgesic affects
and stress hormone responses of subcostal transversus abdominis plane block and local
anesthetic infiltration in patients undergoing laparoscopic surgery. The study is planned to
be prospective, randomized and single-blind.
Description:
Laparoscopic cholecystectomy surgery is an intra-abdominal surgery that is frequently used in
the treatment of gallbladder-related pathologies. With the widespread use of laparoscopic
procedures, open surgery has been replaced by laparoscopic cholecystectomy. Compared to open
surgery, the cost, the risk of bleeding, the risk of surgical site infection are lower, the
need for hospitalization is shorter, and the recovery is rapid.
Post-abdominal pain is carried by T6-L1 thoracolumbar nerves. Pain after laparoscopic
cholecystectomy has both visceral and parietal components, and patients are generally more
bothered by visceral pain after surgery. Visceral pain arises from intraperitoneal
inflammation and increases with coughing, respiratory effort, and mobilization in the
post-operative period, and inadequate analgesia in this period has been associated with
pain-related cognitive dysfunction, atelectasis, thromboembolic events, increased
surgery-related stress response, prolonged hospital stay, and chronic pain in patients.
Acetaminophen, non-steroidal anti-inflammatory drugs, opioid analgesics, intraperitoneal
washing, local anesthesia infiltration and various regional anesthesia techniques can be used
for appropriate analgesia. Studies have shown that subcostal transversus abdominis block has
good analgesic efficacy in laparoscopic cholecystectomy surgeries.
In the perioperative and postoperative period, afferent nerve signals in the surgical
incision area stimulate the hypothalamus, causing the release of CRH, arginine vasopressin,
and cortisol depending on the size of the surgical procedure. Providing appropriate
postoperative analgesia in patients decreased the release of stress hormones cortisol and
prolactin.
In this study, the investigators are aiming to compare the effects of subcostal transversus
abdominis block and local anesthetic infiltration on postoperative analgesia and stress
hormone response in patients who underwent laparoscopic cholecystectomy surgery. The study is
planned to be prospective, randomized and single-blind.