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

Study Description

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Brief Summary:

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 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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
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.
Study Start Date :	November 2011
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Postoperative pain [ Time Frame: 4 h postoperatively ]
   Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h
2. 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.
3. Length of Hospital stay [ Time Frame: 1-5 days ]
   The time to discharge home would be assessed using standardized criteria for home discharge.

Eligibility Criteria

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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

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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

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Responsible Party:	Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier:	NCT01492179 History of Changes
Other Study ID Numbers:	20111212
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