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

NCT ID: NCT01492179

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Uterine Myoma; Persistent Post-menpausal Bleeding; Uterine Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous Lidocaine

Intravenous lidocaine would be administered as an infusion for pain management both intra- and post-operatively.

Group Type: ACTIVE_COMPARATOR

Intravenous Lidocaine

Intervention Type: DRUG

Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.

Intra-abdominal Lidocaine

Lidocaine would be administered intermittently, once each hour intra-abdominally for postoperative pain management.

Group Type: ACTIVE_COMPARATOR

Intra-abdominal Lidocaine

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline would be administered intravenously and intra-abdominally.

Interventions

Normal saline

Normal saline would be administered intravenously and intra-abdominally.

Intervention Type: DRUG

Intravenous Lidocaine

Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Xylocaine 5 mg/ml; Xylocaine 5 mg/ml

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Anil Gupta

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kjell Axelsson, MD, PhD

Role: STUDY_DIRECTOR

Örebro University Hospital, Örebro, Sweden

Locations

Örebro University Hospital

Örebro, , Sweden

Countries

Sweden

Other Identifiers

20111212

Identifier Type: -

Identifier Source: org_study_id