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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01492179

First Posted: December 14, 2011

Last Update Posted: May 28, 2014

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Information provided by (Responsible Party):

Anil Gupta, Örebro University, Sweden

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

MedlinePlus related topics: Anesthesia Hysterectomy

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Anil Gupta, Örebro University, Sweden:

Primary Outcome Measures:

Morphine consumption [ Time Frame: 0 - 24 h postoperatively ]
Total rescue morphine consumption during 0 - 24 h would be the primary endpoint

Secondary Outcome Measures:

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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier:	NCT01492179 History of Changes
Other Study ID Numbers:	20111212
First Submitted:	December 12, 2011
First Posted:	December 14, 2011
Last Update Posted:	May 28, 2014
Last Verified:	May 2014

Keywords provided by Anil Gupta, Örebro University, Sweden:


Surgery: Abdominal hysterectomy Anesthetics: Local Postoperative: Pain Drugs: Morphine

Additional relevant MeSH terms:


Pain, Postoperative Uterine Neoplasms Leiomyoma Myofibroma Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases	Genital Diseases, Female Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms, Connective Tissue Connective Tissue Diseases Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers

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