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

December 13, 2023 updated by: Ilay Cetiner, Sisli Hamidiye Etfal Training and Research Hospital

The Effects of Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration on Post-operative Stress Hormone and Pain Relief After Laparoscopic Cholecystectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 With the widespread use of laparoscopic procedures, open surgery has been replaced by laparoscopic cholecystectomy.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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Istanbul
      • Sisli, Istanbul, Turkey, 34381
        • Sisli Hamidiye Etfal Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 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). VAS score is evaluated between 0 to 10, higher score means worse pain.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress hormone response
Time Frame: 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
5 hours
Analgesia period
Time Frame: 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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Actual)

December 4, 2023

Study Completion (Actual)

December 13, 2023

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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