Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management. (PoPuLAR)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Uterine Myoma Persistent Post-menpausal Bleeding Uterine Cancer |
Drug: Normal saline Drug: Intravenous Lidocaine Drug: Intra-abdominal Lidocaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
- 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
- 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.
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders 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
Contacts and Locations| Contact: Andrea Perniola, MD | +46 19 6020303 | andrea.perniola@orebroll.se |
| Contact: Anil Gupta, MD, PhD | +46 19 6020256 | anil.gupta@orebroll.se |
| Sweden | |
| Örebro University Hospital | Recruiting |
| Örebro, Sweden, 701 85 | |
| Contact: Andrea Perniola, MD +46 19 6020303 andrea.perniola@orebroll.se | |
| Contact: Anil Gupta, MD, PhD +46 19 6020303 anil.gupta@orebroll.se | |
| Study Director: | Kjell Axelsson, MD, PhD | Örebro University Hospital, Örebro, Sweden |
More Information
No publications provided
| Responsible Party: | Anil Gupta, Associate Professor, Örebro University, Sweden |
| ClinicalTrials.gov Identifier: | NCT01492179 History of Changes |
| Other Study ID Numbers: | 20111212 |
| Study First Received: | December 12, 2011 |
| Last Updated: | September 7, 2012 |
| Health Authority: | Institutional Review Board, Sweden: |
Keywords provided by Örebro University, Sweden:
|
Surgery: Abdominal hysterectomy Anesthetics: Local Postoperative: Pain Drugs: Morphine |
Additional relevant MeSH terms:
|
Uterine Neoplasms Hemorrhage Myoma Pain, Postoperative Leiomyoma Myofibroma Pathologic Processes Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Postoperative Complications Pain Signs and Symptoms Neoplasms, Connective Tissue |
Connective Tissue Diseases Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Anesthetics, Local Lidocaine Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013