Effects of Subcostal TAP Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769881
• Other study ID #: 1221
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 13, 2023
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gall Bladder Disease
• Gallbladder Diseases
• Postoperative Pain
• Subcostal Transversus Abdominis Plane Block
• Urinary Bladder Diseases

Intervention

Procedure:
• Ultrasound guided subcostal transversus abdominis plane block
After the induction of anesthesia, before the beginning of the operation, the subcostal transversus abdominis region is going to be detected under ultrasound guidance and 25-30 ml of 0.25% bupivacaine will be administered
• Wound site local anesthetic infiltration
After induction of anesthesia, before the beginning of the operation, a total of 20 ml of 0.25% bupivacaine is going to be infiltrated in equal doses to the four regions that will have trocar access

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Sisli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	Patients are going to be evaluated for 24 hours postoperatively with recording of abdominal pain using the standard 10-cm visual analogue scale (VAS). VAS score is evaluated between 0 to 10, higher score means worse pain.	24 hours
Secondary	Stress hormone response	Blood is going to be taken and recorded in a yellow capped gel biochemistry tube (SSTM II Advance Tubes) for the measurement of stress hormone glucose (70-100mg/dl), prolactin (4.79-23.3µg/dl), cortisol (60.2-184µg/dl) 1 hour before and 1 hour after the operation	5 hours
Secondary	Analgesia period	The time from the end of the operation to the first analgesic requirement was determined as the "analgesic period" and this time is going to be recorded	24 hours