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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01492179
First received: December 12, 2011
Last updated: May 25, 2014
Last verified: May 2014

December 12, 2011
May 25, 2014
November 2011
June 2013   (final data collection date for primary outcome measure)
Morphine consumption [ Time Frame: 0 - 24 h postoperatively ] [ Designated as safety issue: No ]
Total rescue morphine consumption during 0 - 24 h would be the primary endpoint
Same as current
Complete list of historical versions of study NCT01492179 on ClinicalTrials.gov Archive Site
  • Postoperative pain [ Time Frame: 4 h postoperatively ] [ Designated as safety issue: No ]
    Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h
  • Plasma concentration of lidocaine [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The time to discharge home would be assessed using standardized criteria for home discharge.
Same as current
Not Provided
Not Provided
 
Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Uterine Myoma
  • Persistent Post-menpausal Bleeding
  • Uterine Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01492179
20111212
Yes
Anil Gupta, Örebro University, Sweden
Örebro University, Sweden
Not Provided
Study Director: Kjell Axelsson, MD, PhD Örebro University Hospital, Örebro, Sweden
Örebro University, Sweden
May 2014

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