Clinical trial NCT01782781: Local Infiltration Analgesia After Abdominal Hysterectomy
Official title: Local Infiltration Analgesia After Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total morphine consumption
timeFrame: 0-24 hours postoperatively
Secondary outcomes:
measure: Pain intensity (NRS, Numeric Rating Score 0-10)
timeFrame: 0-24 hours postoperatively
measure: Incidence of nausea and vomiting
timeFrame: 0-24 hours postoperatively
measure: Sedation intensity (Ramsey scale)
timeFrame: 0-24 hours postoperatively
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital
Study officials:
affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
name: Sven-Egron Thorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden
name: Anil Gupta, MD, PhD
role: STUDY_CHAIR
affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
name: Ove Carlsson, MD
role: STUDY_CHAIR
affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
name: Karin Olausson, MD
role: STUDY_CHAIR
affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
name: Olof Eckre, MD, PhD
role: STUDY_CHAIR
affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
name: Sven-Erik Ricksten, MD,PhD
role: STUDY_CHAIR
affiliation: Dept. of Gynecological Surgery, Orebro University Hospital, Orebro, Sweden
name: Fatma Backman, MD
role: STUDY_CHAIR
affiliation: Dept. of Gynecological Surgery, Sahlgrenska University Hospital, Goteborg, Sweden
name: Elisabeth Stadberg, MD
role: STUDY_CHAIR
References: