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

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ClinicalTrials.gov Identifier: NCT01492179
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden

Tracking Information
First Submitted Date  ICMJE December 12, 2011
First Posted Date  ICMJE December 14, 2011
Last Update Posted Date May 28, 2014
Study Start Date  ICMJE November 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2011)
Morphine consumption [ Time Frame: 0 - 24 h postoperatively ]
Total rescue morphine consumption during 0 - 24 h would be the primary endpoint
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01492179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2011)
  • Postoperative pain [ Time Frame: 4 h postoperatively ]
    Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h
  • 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.
  • Length of Hospital stay [ Time Frame: 1-5 days ]
    The time to discharge home would be assessed using standardized criteria for home discharge.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Uterine Myoma
  • Persistent Post-menpausal Bleeding
  • Uterine Cancer
Intervention  ICMJE
  • 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.
    Other Name: Xylocaine 5 mg/ml
  • 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
Study Arms  ICMJE
  • Active Comparator: Intravenous Lidocaine
    Intravenous lidocaine would be administered as an infusion for pain management both intra- and post-operatively.
    Intervention: Drug: Intravenous Lidocaine
  • Active Comparator: Intra-abdominal Lidocaine
    Lidocaine would be administered intermittently, once each hour intra-abdominally for postoperative pain management.
    Intervention: Drug: Intra-abdominal Lidocaine
  • 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.
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 13, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01492179
Other Study ID Numbers  ICMJE 20111212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anil Gupta, Örebro University, Sweden
Study Sponsor  ICMJE Örebro University, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kjell Axelsson, MD, PhD Örebro University Hospital, Örebro, Sweden
PRS Account Örebro University, Sweden
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP