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

NCT05769881 | Completed

• 1 other identifier: 1221
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Subcostal Transversus Abdominis Plane Block; Gall Bladder Disease

Keywords

Cholecystectomy, Laparoscopic; Subcostal Transversus Abdominis Plane Block; Analgesia; Cortisol; Prolactin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Stress hormone response

  5 hours

• Analgesia period

  24 hours

Study Arms (2)

Ultrasound guided subcostal transversus abdominis plane block

ACTIVE COMPARATOR

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

Wound site local anesthetic infiltration

ACTIVE COMPARATOR

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

Interventions

Ultrasound guided subcostal transversus abdominis plane block PROCEDURE

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

Ultrasound guided subcostal transversus abdominis plane block

Wound site local anesthetic infiltration PROCEDURE

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

Wound site local anesthetic infiltration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who will undergo laparoscopic cholecystectomy
• ASA I-II
• age group

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Şişli, Istanbul, 34381, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Gallbladder Diseases; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Biliary Tract Diseases; Digestive System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: July 25, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 13, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)