COMPARISON OF TRANSVERSUS ABDOMINIS PLANE BLOCK, LOCAL ANESTHETIC INJECTION TO THE PORT SITES AND INTRAPERITONEAL LOCAL ANESTHESIA APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN PATIENTS WITH LAPAROSCOPIC APPENDECTOMY

NCT03790020 | Completed Phase 4

• 1 other identifier: ANIL ERGIN.....
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The most important determinant of the recovery in abdominal surgery is postoperative pain. Postoperative pain can be explained by 2 pathways connected to the peritoneum; The first is the parietal peritoneum, whose innervation is very rich and the other is the visceral peritoneum which is stimulated at the vagus level. Since 1950, they have been injecting local anesthetic for post-surgery pain. inflammation and peritoneal irritation are the most important factors of pain when acute appendicitis is diagnosed. . This increases the length of hospital stay and increases the cost of pain relief, and reduces patient satisfaction. The aim of this study is to evaluate the application of Transversus Abdominis Plane Block . local anesthetic injection to the port sites, intraperitoneal periappendiceal local anesthetic injection is compared with the control group without any local anesthetic application to investigate which group has more analgesic effectiveness and thus reduce the amount of analgesics needed postoperatively, hospitalization Shortening the duration of the patient and taking the patient comfort to the next level.

Conditions

Postoperative Pain

Keywords

acute appendicitis; postoperative pain relief; local anesthetic; laparoscopic appendectomy

Outcome Measures

Primary Outcomes (1)

• compare of local anesthetic applying methods for postoperative pain relief by VAS (Visual Analog Scala)

  pain scores of the participants will be followed at postoperative 1,2,4,6,12,24 hour (up to 24 hours). (VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.

  24 hours

Study Arms (4)

transversus abdominis plane Block

ACTIVE COMPARATOR

Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.

Drug: Bupivacaine

TROCHAR SITES LOCAL ANESTHETIC INJECTION

ACTIVE COMPARATOR

local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution to be applied)

Drug: Bupivacaine

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD

ACTIVE COMPARATOR

Intraperitoneal direct vision of the appendix excision area-periappendiciall area under the direct injection of local anesthetic spraying process (percutaneous method injected into the periappendicial area 1: 1 diluted with 20 cc SF, 20 cc 0.5% bupivacaine solution total 40 cc spraying will be applied.

Drug: Bupivacaine

CONTROL GROUP

NO INTERVENTION

group will be the control group and any of these methods will not be applied,

Interventions

Bupivacaine DRUG

In our study this local anesthetic agent will be applied for postoperative pain relief

Also known as: marcaine

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD; TROCHAR SITES LOCAL ANESTHETIC INJECTION; transversus abdominis plane Block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age with acute appendicitis in emergency department

You may not qualify if:

• Patients who have to undergo peroperative open appendectomy procedure.
• Patients with local anesthetic or non steroid antiinflammatory allergy
• Patients in pregnancy
• Patients with connective tissue disease
• Patients with malignancy detected in pathological examination of postoperative appendix and patients with any malignancy diagnosis
• Perforated patients peroperatively
• Patients who were evaluated as plastron appendicitis peroperatively

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Appendicitis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asistant doctor

Model Details: 3 types of local anesthetic applying method will be compared

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 31, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)