Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Shoulder Pain; Complication; Satisfaction

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 Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34300
    • Turgut Donmez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient aged 18-70 years diagnosed with ASA I, II and III acute cholecystitis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1.Intraoperative bupivacaine; intraperitoneal bupivacaine wash-emergency laparoscopic cholecystectomy
Group 2.Intravenous paracetamol; intravenous paracetamol-emergency laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Shoulder Pain	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.	postoperative 1st day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Abdominal Pain 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.	pain at postoperative 2nd hour
operation time	duration of operation(minutes), time from anesthesia induction to extubation of the patient	up to 100 minutes
Change in C -reactive protein (CRP) level in all study participants	Compare the postoperative 1st day CRP levels with the baseline CRP in study patients. Comparison will be performed using a paired t-test.	preoperative and postoperative 1st day
Change in alanine aminotransferase (ALT) level in all study participants	Compare the postoperative 1st day ALT levels with the baseline ALT in study patients. Comparison will be performed using a paired t-test.	preoperative and postoperative 1st day
Change in Aspartate Aminotransferase (AST) level in all study participants	Compare the postoperative 1st day AST levels with the baseline AST in study patients. Comparison will be performed using a paired t-test.	preoperative and postoperative 1st day
Post-operative Abdominal Pain 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.	pain at postoperative 6th hour
Post-operative Abdominal Pain 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.	pain at postoperative 12th hour
Post-operative Abdominal Pain 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.	pain at postoperative 24th hour

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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;(3):CD009060. doi: 10.1002/14651858.CD009060.pub2.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2018
• Primary Completion (ACTUAL): January 9, 2019
• Study Completion (ACTUAL): March 14, 2019

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (ACTUAL): October 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Gallbladder Diseases; Biliary Tract Diseases; Abdominal Pain; Shoulder Pain; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: BakirköyEAH 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After the patients are included in the study, the patient data will be entered into the system and the results will be evaluated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No