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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492179
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Myoma Persistent Post-menpausal Bleeding Uterine Cancer Drug: Normal saline Drug: Intravenous Lidocaine Drug: Intra-abdominal Lidocaine Phase 4

Detailed Description:

Abdominal hysterectomy with or without salipingo-oophorectomy is associated with moderate-severe postoperative pain. Poor pain control in the postoperative period can lead to increased postoperative morbidities and poor quality of life. Furthermore, an emerging clinical literature suggests that acute pain may rapidly evolve into chronic pain if poorly treated. A meta-analysis of the literature found that > 30% patients had chronic pain one year after abdominal hysterectomy (5). Therefore, efficient postoperative pain management is imperative for the patient and is one of the new pain management standards recommended recently.

Local anesthetics (LA) have been infiltrated subcutaneously, infused intra-abdominally, as well as injected into the peritoneal cavity as a single dose at the end of the operation following abdominal hysterectomy with variable effects. When injected as a single dose, analgesia is limited to approximately 2-4 hours due to the short duration of action of local anesthetics. In one recent study, the authors used a catheter inserted intra-abdominally and local anesthetic or placebo infusion into the abdominal cavity for 24 h postoperatively and found a reduction in postoperative analgesic requirements by 40% during 4-24 h. In another study, the investigators found that LA injected intermittently intra-abdominally resulted in better pain relief compared to intra-abdominal infusions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Between Continuous Infusion vs. Patient Controlled Intraabdominal Injection of Local Anesthetics for Treatment of Postoperative Pain After Abdominal Hysterectomy. A Randomized, Double-blind Study.
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intravenous Lidocaine
Intravenous lidocaine would be administered as an infusion for pain management both intra- and post-operatively.
Drug: Intravenous Lidocaine
Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.
Other Name: Xylocaine 5 mg/ml

Active Comparator: Intra-abdominal Lidocaine
Lidocaine would be administered intermittently, once each hour intra-abdominally for postoperative pain management.
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
Other Name: Xylocaine 5 mg/ml

Placebo Comparator: Normal saline
Normal saline would be administered intra-abdominally and intravenously in the same patient. Rescue analgesia in the form of morphine (PCA) would be used for pain management.
Drug: Normal saline
Normal saline would be administered intravenously and intra-abdominally.

Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: 0 - 24 h postoperatively ]
    Total rescue morphine consumption during 0 - 24 h would be the primary endpoint

Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 4 h postoperatively ]
    Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h

  2. Plasma concentration of lidocaine [ Time Frame: 24 h ]
    The plasma concentration of LA lidocaine would be analysed at 24 h in order to assess whether the LA absorption from the abdomen is similar to that administered intravenously.

  3. Length of Hospital stay [ Time Frame: 1-5 days ]
    The time to discharge home would be assessed using standardized criteria for home discharge.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA 1-2
  • 30 - 75 yrs
  • Informed consent
  • 50 - 100 kg

Exclusion Criteria:

  • Allergy to LA
  • Chronic pain
  • Major liver/kidney insufficiency
  • AV Block 1-2 Participation in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492179

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Örebro University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Örebro University, Sweden
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Study Director: Kjell Axelsson, MD, PhD Örebro University Hospital, Örebro, Sweden
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Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden Identifier: NCT01492179    
Other Study ID Numbers: 20111212
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014
Keywords provided by Anil Gupta, Örebro University, Sweden:
Surgery: Abdominal hysterectomy
Anesthetics: Local
Postoperative: Pain
Drugs: Morphine
Additional relevant MeSH terms:
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Uterine Neoplasms
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Neurologic Manifestations
Signs and Symptoms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers