Effects of Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05769881
Collaborator
(none)
70
1
2
3.3
21.5

Study Details

Study Description

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 our study, we 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. Our study is planned to be prospective, randomized and single-blind.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound guided subcostal transversus abdominis plane block
  • Procedure: Wound site local anesthetic infiltration
N/A

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 With the widespread use of laparoscopic procedures, open surgery has been replaced by laparoscopic cholecystectomy.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, we 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. Our study is planned to be prospective, randomized and single-blind.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jun 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

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

Active Comparator: 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.

Procedure: 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

Outcome Measures

Primary Outcome Measures

  1. VAS score [24 hours]

    Patients are going to be evaluated for 24 hours postoperatively with recording of abdominal pain using the standard 10-cm visual analogue scale (VAS)

Secondary Outcome Measures

  1. Stress hormone response [5 hours]

    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

  2. Analgesia period [24 hours]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sisli Hamidiye Etfal Training and Research Hospital Sisli Istanbul Turkey 34381

Sponsors and Collaborators

  • Sisli Hamidiye Etfal Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ilay Cetiner, principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05769881
Other Study ID Numbers:
  • 1221
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ilay Cetiner, principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023