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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 (APPENDECTOMY)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring acute appendicitis, postoperative pain relief, local anesthetic, laparoscopic appendectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fatih Sultan Mehmet Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

transversus abdominis plane Block

TROCHAR SITES LOCAL ANESTHETIC INJECTION

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD

CONTROL GROUP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2018
Last Updated
March 19, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03790020
Brief Title
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
Acronym
APPENDECTOMY
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
acute appendicitis, postoperative pain relief, local anesthetic, laparoscopic appendectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
3 types of local anesthetic applying method will be compared
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transversus abdominis plane Block
Arm Type
Active Comparator
Arm Description
Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.
Arm Title
TROCHAR SITES LOCAL ANESTHETIC INJECTION
Arm Type
Active Comparator
Arm Description
local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution to be applied)
Arm Title
INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
group will be the control group and any of these methods will not be applied,
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
In our study this local anesthetic agent will be applied for postoperative pain relief
Primary Outcome Measure Information:
Title
compare of local anesthetic applying methods for postoperative pain relief by VAS (Visual Analog Scala)
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fatih Sultan Mehmet Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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