Local Infiltration Analgesia After Abdominal Hysterectomy

Pain Clinical Trial

— LIA  

Official title:

Local Infiltration Analgesia After Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782781
• Other study ID #: LIA-AH-1
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2013
• Last updated: January 19, 2015
• Start date: November 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Data Inspection BoardSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery.

Description:

The study is a controlled, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden. The injectant mixture consists of 300 mg ropivacaine mixed with 30 mg ketorolac and 0.5 mg epinephrine. Total volume of the solution is 156 ml. The normal saline injection is used in the control group in the same manner as in the LIA group. The parameters which would be evaluated are consumption of morphine, pain intensity and side effects.

The primary objective is to evaluate whether local infiltration analgesia (LIA) into the operating field will reduce morphine consumption during the first 24 postoperative hours in patients undergoing abdominal hysterectomy (AH).

Secondary end-points are pain intensity, incidence of nausea and vomiting, sedation intensity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients requiring abdominal hysterectomy

Exclusion Criteria:

• Body mass index > 35

• American Society of Anesthesiologists classification > 3

• Renal dysfunction

• Allergic to acetylsalicylic acid

• Unwilling to provide informed consent

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

• Pain

Intervention

Drug:
• ropivacaine, ketorelac and epinephrine
Active group
• Placebo
Placebo group

Locations

Country	Name	City	State
Sweden	Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption		0-24 hours postoperatively	Yes
Secondary	Pain intensity (NRS, Numeric Rating Score 0-10)		0-24 hours postoperatively	Yes
Secondary	Incidence of nausea and vomiting		0-24 hours postoperatively	Yes
Secondary	Sedation intensity (Ramsey scale)		0-24 hours postoperatively	Yes