Postoperative Pain Difference for 'IV Paracetamol' and TAP Block' in Acute Cholecystitis

NCT ID: NCT04767542

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2021-10-15

Brief Summary

Patients with acute cholecystitis or pancreatitis due to gallstones benefit from emergency laparoscopic cholecystectomy (LC). Patients with emergency LC show improvement in their quality of life within one month compared to those treated. Delayed LC (after the acute phase has passed and recovered) and less time to work. This strategy reduces the risk of repeated admissions with more pain or pancreatitis. There are many studies on the effectiveness of the Elective LC and Transversus Abdominis Plan (TAP) Block on pain. However, a prospective study on the reduction of postoperative pain with emergency LC and TAP Block has not been carried out until now. This study will be conducted to evaluate the effectiveness of the TAP Block in patients undergoing emergency LC.

Detailed Description

Patients to be included in the study will be selected from the group between the ages of 18 and 70 who apply to general surgery and emergency outpatient clinics, depending on patient approval. All patients will be informed about the surgery and procedures to be performed. Patients who agree to participate in the study will be included in the study. The study will be carried out by 2 surgeons with 5 years of laparoscopic cholecystectomy (LC) experience. Adult patients presenting with acute cholecystitis who underwent emergency LC by one of the two surgeons will be included in the study. These two surgeons will be responsible for participant registration. Patients with fever greater than 3.37.2 ℃, including 1) a diagnosis of acute cholecystitis confirmed by hepatobiliary ultrasound, 2) a high leukocyte count (> 7 × 109 / L), will be included in the study. Patients undergoing elective laparoscopic cholecystectomy (E-LC) and patients who are converted to an open procedure will be excluded from the study. Patients will be divided into two groups. In Group A, patients with emergency LC will be administered intravenously 1 gr vial of paracetemol in 30 minutes during the awakening phase. In Group B, the lateral part of the latissumus dorsi muscle attaches to the external lip of the iliac crest, behind the middle axillary line and the end is directed towards the cranial, firstly the external oblique muscle and fascia, then the internal oblique muscle and fascia, and after hydrodissection with saline physiological. 15-20 ml of local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally.

Standard laparoscopic cholecystectomy will be applied in two groups. Nasogastric tube will be inserted after intubation in both groups and will be removed at the end of the operation. Age, height, weight, ASA score, body mass index, duration of surgery, complications, comorbidities, fever, leukocyte, CRP levels, ALT, AST, GGT, total bilirubin, direct bilirubin values will be recorded. Pulse, heart rate, systolic and diastolic pressures, Oxygen saturation (with a palimeter) will be recorded during surgery in both groups. VAS and VRS pain scoring will be done after surgery. VAS (Visuale analogue score) 0-10 cm and VRS (no pain in cough (score = 0); pain in cough, not in deep breathing (score = 1); pain in deep breathing, but not at rest (score = 2); at rest pain will be evaluated as mild (score = 3); pain at rest, severe (score = 4)). Evaluations will be made statistically between the two groups.

Conditions

Transversus Abdominis Plane (TAP) Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Paracetamol

Patients with emergency LC will be administered intravenously 1 gr vial of paracetemol in 30 minutes during the awakening phase.

Group Type: SHAM_COMPARATOR

Intravenous Infusion

Intervention Type: DRUG

analgesic

Transversus Abdominis Plane Block

With USG, the lateral part of the latissumus dorsi muscle attaches to the external lip of the iliac crest, just behind the middle axillary line and the end is directed slightly cranially, first through the external oblique muscle and fascia, then the internal oblique muscle and fascia, and after hydrodissection with saline for about 15-20 ml of local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally

Group Type: ACTIVE_COMPARATOR

Local anesthesia

Intervention Type: PROCEDURE

Local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally to transverses abdominis muscle

Interventions

Intravenous Infusion

analgesic

Intervention Type: DRUG

Local anesthesia

Local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally to transverses abdominis muscle

Intervention Type: PROCEDURE

Other Intervention Names

Paracetamol

Eligibility Criteria

Inclusion Criteria

• Acute stony cholecystitis
• Acute acalculous cholecystitis
• 18-70 years old

Exclusion Criteria

• Open cholecystectomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Turgut Donmez

Ass. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Turgut Donmez, Ass. Prof.

Role: STUDY_DIRECTOR

Bakirkoy Sadi Konuk

Central Contacts

Husnu Aydin, MD

Role: CONTACT

drhusnuaydin@gmail.com

00905322471152

References

Yahya Gumusoglu A, Ferahman S, Gunes ME, Surek A, Yilmaz S, Aydin H, Gezmis AC, Aliyeva Z, Donmez T. High-Volume, Low-Concentration Intraperitoneal Bupivacaine Study in Emergency Laparoscopic Cholecystectomy: A Double-Blinded, Prospective Randomized Clinical Trial. Surg Innov. 2020 Oct;27(5):445-454. doi: 10.1177/1553350620914198. Epub 2020 Apr 3.

Reference Type: BACKGROUND

PMID: 32242764 (View on PubMed)

Peng K, Ji FH, Liu HY, Wu SR. Ultrasound-Guided Transversus Abdominis Plane Block for Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Med Princ Pract. 2016;25(3):237-46. doi: 10.1159/000444688. Epub 2016 Feb 16.

Reference Type: RESULT

PMID: 26885872 (View on PubMed)

Other Identifiers

Bakirkoy Sadi Konuk

Identifier Type: -

Identifier Source: org_study_id