Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis

NCT03708874 | Completed DMC

• 1 other identifier: BakirköyEAH 2
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain; Shoulder Pain; Satisfaction; Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Post-operative Abdominal Pain 2nd Hour

  pain at postoperative 2nd hour

• operation time

  up to 100 minutes

• Change in C -reactive protein (CRP) level in all study participants

  preoperative and postoperative 1st day

• Change in alanine aminotransferase (ALT) level in all study participants

  preoperative and postoperative 1st day

• Change in Aspartate Aminotransferase (AST) level in all study participants

  preoperative and postoperative 1st day

Study Arms (2)

Group 1.Intraoperative bupivacaine

intraperitoneal bupivacaine wash-emergency laparoscopic cholecystectomy

Group 2.Intravenous paracetamol

intravenous paracetamol-emergency laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Acute stone cholecystitis
• Acute acrylic cholecystitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Turgut Donmez

Istanbul, 34300, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 24668032 RESULT

• 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.

  PMID: 29340809 RESULT

• 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.

  PMID: 23742777 RESULT

MeSH Terms

Conditions

Abdominal Pain; Shoulder Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Turgut Donmez, surgeon

  Bakirkoy Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Mehmet Emin Gunes, MD

  Bakirkoy Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 17, 2018
• Study Start: October 9, 2018
• Primary Completion: January 9, 2019
• Study Completion: March 14, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)