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
  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.

Resource links provided by NLM:


Further study details as provided by Örebro University, Sweden:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492179

Locations
Sweden
Örebro University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Örebro University, Sweden
Investigators
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: May 25, 2014
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:
Hemorrhage
Myoma
Pain, Postoperative
Leiomyoma
Myofibroma
Uterine Neoplasms
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 August 19, 2014