Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03708874

Collaborator

(none)

Enrollment

Location

5.1

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients diagnosed with acute cholecystitis benefit from emergency laparoscopic cholecystectomy (LC). Patients who had emergency LC showed improvement in quality of life in one month compared to those treated. Delayed LC (after the acute cholecystitis has passed) and less time to recover from work. This strategy reduces the risk of repeated referrals with more pain or pancreatitis. There are many studies on the efficacy of intraoperative intraperitoneal bupivacaine(IPBV) with elective LC on pain of IPBV. However, the prospective study of reducing the postoperative pain of emergency LC - IPBV is very few. This study will be conducted to evaluate the efficacy of IPBV in patients with emergency LC.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Pain Shoulder Pain Satisfaction Complication

Detailed Description

Patients to be included in the study will be selected from the group between 18 and 70 years of age who apply to general surgery and emergency policlinics, depending on patient approval. All patients will be informed about the operation and the procedures to be performed. Patients who accepted to participate in the study will be included in the study and randomization will be performed by randomly selected patients and two groups. The study will be carried out by 2 surgeons with 5 years of laparoscopic cholecystectomy (LC).Adult patients presenting with acute cholecystitis treated by emergency surgeons by one of two surgeons will be included in the study. These two surgeons will be responsible for the participant records. 1.hepatobiliary ultrasound-confirmed acute cholecystitis diagnosis, 2. Patients undergoing elective laparoscopic cholecystectomy (el-LC) will not be included in the study. Patients converted into an open procedure will be excluded from the study. Patients will be divided into two groups. In Group A, intravenous 1 gr paracetamol via will be applied in 30 minutes after waking up.In Group B, immediately after the introduction of intraoperative laparoscopic trocars, 480 ml of saline + 20 ml of 5% bupivacaine solution will be washed in the subdiaphragmatic area, gallbladder region and the entire abdomen. In both groups, standard laparoscopic cholecystectomy will be performed. In both groups, nasogastric tube will be inserted at the end of the operation after intubation. , CRP(C-reactive protein) levels, ALT(Alanine Aminotransferase) , AST(Aspartate Aminotransferase), GGT(Gamma-Glutamyltransferase), total bilirubin, direct bilirubin values will be recorded. Pulse, heart rate, systolic and diastolic pressures, Oxygen saturation (with pulse) during surgery will be recorded in both groups. Post-operative VAS(Visual analogue score) and VRS(Verbal Rating Scales) pain scores will be performed. VAS 0-10 cm and VRS (no pain in cough (score = 0); pain in cough, not in deep breathing (score = 1); resting (score = 2), pain at rest, mild (score = 3); pain at rest, severe (score = 4)) will be evaluated as.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Comparison of Intravenous Paracetamol and Intraperitoneal Bupivacaine for Acute Laparoscopic Cholecystectomy Pain Relief in Patients With Acute Cholecystitis. A Prospective Randomized Clinical Trial

Actual Study Start Date :

Oct 9, 2018

Actual Primary Completion Date :

Jan 9, 2019

Actual Study Completion Date :

Mar 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group 1.Intraoperative bupivacaine intraperitoneal bupivacaine wash-emergency laparoscopic cholecystectomy
Group 2.Intravenous paracetamol intravenous paracetamol-emergency laparoscopic cholecystectomy

Outcome Measures

Primary Outcome Measures

Post-operative Shoulder Pain [postoperative 1st day]
Group 1 and Group 2 Post-operative shoulder pain. VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.

Secondary Outcome Measures

Post-operative Abdominal Pain 2nd Hour [pain at postoperative 2nd hour]
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
operation time [up to 100 minutes]
duration of operation(minutes), time from anesthesia induction to extubation of the patient
Change in C -reactive protein (CRP) level in all study participants [preoperative and postoperative 1st day]
Compare the postoperative 1st day CRP levels with the baseline CRP in study patients. Comparison will be performed using a paired t-test.
Change in alanine aminotransferase (ALT) level in all study participants [preoperative and postoperative 1st day]
Compare the postoperative 1st day ALT levels with the baseline ALT in study patients. Comparison will be performed using a paired t-test.
Change in Aspartate Aminotransferase (AST) level in all study participants [preoperative and postoperative 1st day]
Compare the postoperative 1st day AST levels with the baseline AST in study patients. Comparison will be performed using a paired t-test.
Post-operative Abdominal Pain 6th Hour [pain at postoperative 6th hour]
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Post-operative Abdominal Pain 12th Hour [pain at postoperative 12th hour]
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Post-operative Abdominal Pain 24th Hour [pain at postoperative 24th hour]
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute stone cholecystitis
Acute acrylic cholecystitis

Exclusion Criteria:

Cholecystitis with chronic stones
Gallbladder polyps,
Patients with bleeding diathesis,
Allergy to local anesthetic agents,
Patients with paracetamol group allergy,
Choledocholithiasis associated with acute cholecystitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turgut Donmez	Istanbul		Turkey	34300

Sponsors and Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

Principal Investigator: Turgut Donmez, surgeon, Bakirkoy Training and Research Hospital
Study Director: Mehmet Emin Gunes, MD, Bakirkoy Training and Research Hospital