Clinical trial NCT03708874: Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Pain
Shoulder Pain
Satisfaction
Complication
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient aged 18-70 years diagnosed with ASA I, II and III acute cholecystitis

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative Shoulder Pain
timeFrame: postoperative 1st day
Secondary outcomes:
measure: Post-operative Abdominal Pain 2nd Hour
timeFrame: pain at postoperative 2nd hour
measure: operation time
timeFrame: up to 100 minutes
measure: Change in C -reactive protein (CRP) level in all study participants
timeFrame: preoperative and postoperative 1st day
measure: Change in alanine aminotransferase (ALT) level in all study participants
timeFrame: preoperative and postoperative 1st day
measure: Change in Aspartate Aminotransferase (AST) level in all study participants
timeFrame: preoperative and postoperative 1st day
measure: Post-operative Abdominal Pain 6th Hour
timeFrame: pain at postoperative 6th hour
measure: Post-operative Abdominal Pain 12th Hour
timeFrame: pain at postoperative 12th hour
measure: Post-operative Abdominal Pain 24th Hour
timeFrame: pain at postoperative 24th hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Turgut Donmez
Study officials:
affiliation: Bakirkoy Training and Research Hospital
name: Turgut Donmez, surgeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakirkoy Training and Research Hospital
name: Mehmet Emin Gunes, MD
role: STUDY_DIRECTOR
References:
citation: Gurusamy KS, Nagendran M, Toon CD, Guerrini GP, Zinnuroglu M, Davidson BR. Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 25;2014(3):CD009060. doi: 10.1002/14651858.CD009060.pub2.
citation: Kaushal-Deep SM, Anees A, Khan S, Khan MA, Lodhi M. Randomized controlled study of intraincisional infiltration versus intraperitoneal instillation of standardized dose of ropivacaine 0.2% in post-laparoscopic cholecystectomy pain: Do we really need high doses of local anesthetics-time to rethink! Surg Endosc. 2018 Jul;32(7):3321-3341. doi: 10.1007/s00464-018-6053-z. Epub 2018 Jan 16.
citation: Roberts KJ, Gilmour J, Pande R, Hodson J, Lam FT, Khan S. Double-blind randomized sham controlled trial of intraperitoneal bupivacaine during emergency laparoscopic cholecystectomy. Hepatobiliary Pancreat Dis Int. 2013 Jun;12(3):310-6. doi: 10.1016/s1499-3872(13)60049-1.