Local Infiltration Analgesia After Abdominal Hysterectomy

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: ropivacaine, ketorelac and epinephrine

• Registration Number: NCT01782781
• Lead Sponsor: Göteborg University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-04
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Placebo	Group P (Placebo) receives a local infiltration of saline in the operating field and ketorolac iv. In Group P the injectant consists of saline, total volume 156 mL. This is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. Ketorolac 30 mg (1 mL) is also injected iv.
Group A	ropivacaine, ketorelac and epinephrine	Group A (Active) receives a local infiltration of ropivacaine, ketorolac and epinephrine in the operating field and saline iv. Drug: ropivacaine, ketorelac and epinephrine In Group A the injectant mixture consists of ropivacaine 300 mg mixed with 30 mg ketorolac and 0.5 mg epinephrine, total volume 156 mL. This mixture is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. One mL saline is also injected iv.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	0-24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Incidence of nausea and vomiting	0-24 hours postoperatively
Sedation intensity (Ramsey scale)	0-24 hours postoperatively
Pain intensity (NRS, Numeric Rating Score 0-10)	0-24 hours postoperatively

Trial Locations

Locations (1)

Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital; 🇸🇪 Goteborg, Sweden