Clinical trial NCT05769881: Effects of Subcostal TAP Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy
Official title: The Effects of Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration on Post-operative Stress Hormone and Pain Relief After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Subcostal Transversus Abdominis Plane Block
Gall Bladder Disease
Keywords: Cholecystectomy, Laparoscopic
Subcostal Transversus Abdominis Plane Block
Analgesia
Cortisol
Prolactin
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* who will undergo laparoscopic cholecystectomy
* ASA I-II
* 18-65 age group

Exclusion Criteria:

* Pregnant
* Emergency surgery
* ASA III-IV
* History of local anesthetic allergy
* Coagulative disorder
* Corticosteroid use
* Severe psychiatric disease
* History of chronic pain
* Uncooperative patients
* Neurological deficit

Primary outcomes:
measure: VAS score
timeFrame: 24 hours
Secondary outcomes:
measure: Stress hormone response
timeFrame: 5 hours
measure: Analgesia period
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sisli
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
state: Istanbul
Study officials:
References: