Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Suspected Appendicitis Clinical Trial

Official title:

Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711449
• Other study ID #: 2015-810
• Secondary ID: 2015-004800-46
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2016
• Last updated: September 24, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative pain after laparoscopy for suspected appendicitis and to test whether preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.

Description:

Patients enrolled are randomized to active substance or placebo approximately 30 minutes prior to skin incision.

Patients are followed for 30 days postoperative with registration of outcomes on a postoperative questionnaire. Patients are contacted by telephone at every registration time. The primary outcome is also secured over the telephone in case patients do not return their questionnaire.

With a power of 80% and a significance level of 5% we need 64 patients (32 in each arm) to show a 30% reduction in postoperative pain during the first 3 postoperative days with 5 measurements and we need 42 patients (21 in each arm) to show a 15% increase in the QoR-15 during the first 3 postoperative days. With an anticipated loss to follow up of 20% we need 80 patients ( 40 in each arm).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Laparoscopy for suspected appendicitis

• Age 18 years or older

• American Society of Anesthesiologist (ASA) class I-III.

• Gives written and oral consent

Exclusion Criteria:

• Known inflammatory bowel disease.

• Known autoimmune disease.

• Chronic pain patient.

• Presumed poor compliance.

• Pregnant or breastfeeding.

• In systematic treatment with glucocorticoids or other immunosuppressive treatment.

• Known renal disease, GFR<30.

• Known liver cirrhosis.

• Known heart failure, EF<40%.

• Known glaucoma.

• Known ocular herpes simplex.

• Known cushings disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Suspected Appendicitis

Intervention

Drug:
• Methylprednisolone
125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.
• 0.9% Saline
0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Locations

Country	Name	City	State
Denmark	Nordsjaellands Hospital	Hillerød
Denmark	Køge Sygehus	Køge

Sponsors (2)

Lead Sponsor	Collaborator
Jakob Kleif	Koege Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at rest during the first 3 postoperative days on a 11-point NRS	Powered to detect 30% reduction, Random regression model (mixed effects model)	6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3	No
Secondary	Pain when coughing during the first 3 postoperative days on a 11-point NRS	Random regression model (mixed effects model)	6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3	No
Secondary	Fatigue during the first 3 postoperative days on a 11-point NRS	Random regression model (mixed effects model)	6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3	No
Secondary	Sleep during the first 3 postoperative days on a 11-point NRS		postoperative day (POD) 1, POD2 and POD3	No
Secondary	QoR-15 during the first 3 postoperative days	Powered to detect 15% increase,	postoperative day (POD) 1, POD2 and POD3	No
Secondary	Incidence of postoperative nausea or vomiting during the first postoperative day		6 hours, 12 hours and 24-32 hours postoperative	No
Secondary	Pain at rest after POD3 on a 11-point NRS		postoperative day (POD) 7, POD 14 and POD 30	No
Secondary	Pain when coughing after POD3 on a 11-point NRS		postoperative day (POD) 7, POD 14 and POD 30	No
Secondary	Fatigue after POD3 on a 11-point NRS		postoperative day (POD) 7, POD 14 and POD 30	No
Secondary	Sleep after POD3 on a 11-point NRS		postoperative day (POD) 7, POD 14 and POD 30	No
Secondary	QoR-15 after POD 3		postoperative day (POD) 7, POD 14 and POD 30	No
Secondary	Mobilization during the first postoperative day on a 4-point likert scale		6 hours, 12 hours and postoperative day 1	No
Secondary	Resumption of occupational activity	Number of days from surgery until resumption of occupational activities	Up to 60 days postoperative	No
Secondary	Resumption of recreational activity	Number of days from surgery until resumption of recreational activities	Up to 60 days postoperative	No
Secondary	Duration of convalescence	Number of days from surgery until resumption of both occupational and recreational activities	Up to 60 days postoperative	No
Secondary	Adverse events according to GCP guidelines		30 day postoperative	Yes
Secondary	Postoperative complications according to the Clavien-Dindo classification		30 day postoperative	Yes
Secondary	Opioid consumption during the first 24 hours postoperative	Both as a the need for opioids and the amount equivalent to intravenous morphine.	24 hours postoperative	No
Secondary	Need for rescue antiemetics during the first 24 hours postoperative		24 hours postoperative	No
Secondary	Duration of postoperative hospital stay	The duration of the postoperative hospital stay in hours.	30 days postoperative	No