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Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis

B

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status

Completed

Conditions

Shoulder Pain
Complication
Satisfaction
Abdominal Pain

Study type

Observational

Funder types

Other

Identifiers

NCT03708874
BakirköyEAH 2

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

2 participants in 2 patient groups

Group 1.Intraoperative bupivacaine
Description:
intraperitoneal bupivacaine wash-emergency laparoscopic cholecystectomy
Group 2.Intravenous paracetamol
Description:
intravenous paracetamol-emergency laparoscopic cholecystectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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