Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management. (PoPuLAR)
|ClinicalTrials.gov Identifier: NCT01492179|
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : May 28, 2014
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Morphine consumption [ Time Frame: 0 - 24 h postoperatively ]Total rescue morphine consumption during 0 - 24 h would be the primary endpoint
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492179
|Örebro University Hospital|
|Örebro, Sweden, 701 85|
|Study Director:||Kjell Axelsson, MD, PhD||Örebro University Hospital, Örebro, Sweden|