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Local Infiltration Analgesia After Abdominal Hysterectomy

Local Infiltration Analgesia After Abdominal Hysterectomy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01782781
Acronym
LIA
Enrollment
60
Registered
2013-02-04
Start date
2012-11-30
Completion date
2014-10-31
Last updated
2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Analgesia, Local infiltration analgesia, Pain, relief, Pain, Postoperative, Ropivacaine, Ketorolac, Epinephrine, Adrenergic Agonists, Sympathomimetics, Therapeutic Uses, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Opioids, Morphine, Pain, Postoperative Complications, Physiological Effects of Drugs, Anesthetics, Local, Anesthetics

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.

Interventions

DRUGPlacebo

Placebo group

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total morphine consumption0-24 hours postoperatively

Secondary

MeasureTime frame
Pain intensity (NRS, Numeric Rating Score 0-10)0-24 hours postoperatively
Incidence of nausea and vomiting0-24 hours postoperatively
Sedation intensity (Ramsey scale)0-24 hours postoperatively

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026