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

NCT ID: NCT03790020

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-03-01

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.

Detailed Description

Laparoscopic Appendectomy procedure will be performed in patients over 18 years of age who are hospitalized from the emergency department for acute appendicitis. 4 patient group will be established. The number of samples determined for Power: 0.80 and alpha: 0.05 was determined as minimum n: 28 for each group. Therefore, the groups will be determined to include 28 patients. In our clinic, local anesthetic injection to the trocar areas is routinely performed in laparoscopic appendectomy operations. After endotracheal intubation at the beginning of the operation, after appropriate skin staining and sterile dressing Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied. local anesthetic injection to the pre-incision trocar sites (8 cc instead of infraumbilical trocar, 6 cc instead of the other 2 trocar 20 cc 0.5% bupivacaine solution will be applied), following intraperitoneal direct visualization of the appendiceal region - local anesthetic spraying into the periappendiceal area(1: 1 diluted with 20 cc saline, 20 cc 0.5% bupivacaine solution total 40 cc spraying ) will be applied. The fourth group will be the control group and any of these methods will not be applied, operation time and peroperative complications (appendiceal perforation etc.) will be recorded.Paracetamol 1 g + 1 mg / kg tramadol IV will be applied to all four groups as standard before extubation. Visual analogue scale (VAS) will be applied to all patients in the postoperative period. If VAS> 3 is still present, a dose of 1 mg / kg tramadol will be administered. Tenoxicam 1x1 IV will be applied to the patients on the 12th hour. All patients were postoperative; 1,2,4,6,12,24. VAS scores , patient satisfaction (0: never satisfied, 5: very satisfied) will be recorded. The group of patients will be determined according to the order of surgery. Pain scores of the patients will be performed by a physician who is not in the operation who does not know which group is taken. The patients included in the group will not be known to the patient by the pain scoring system and the study will be done as double blind. Patients will be randomized with this method.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

transversus abdominis plane Block

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

TROCHAR SITES LOCAL ANESTHETIC INJECTION

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

CONTROL GROUP

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bupivacaine

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

Intervention Type: DRUG

Other Intervention Names

marcaine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

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

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

ANIL ERGIN

asistant doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ANIL ERGIN.....

Identifier Type: -

Identifier Source: org_study_id