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Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.

NCT01492179 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-05-28

No results posted yet for this study

Summary

Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.

Conditions

  • Uterine Myoma
  • Persistent Post-menpausal Bleeding
  • Uterine Cancer

Interventions

DRUG

Normal saline

Normal saline would be administered intravenously and intra-abdominally.

DRUG

Intravenous Lidocaine

Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.

DRUG

Intra-abdominal Lidocaine

Lidocaine 5 mg/ml; 100 mg would be administered intraoperatively intra-abdominally and subsequently 50 mg/h as intermittent injection intra-abdominally during 24 h

Sponsors & Collaborators

  • Örebro University, Sweden

    lead OTHER

Principal Investigators

  • Kjell Axelsson, MD, PhD · Örebro University Hospital, Örebro, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01492179 on ClinicalTrials.gov