Clinical trial NCT01492179: Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Myoma
Persistent Post-menpausal Bleeding
Uterine Cancer
Keywords: Surgery: Abdominal hysterectomy
Anesthetics: Local
Postoperative: Pain
Drugs: Morphine
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morphine consumption
timeFrame: 0 - 24 h postoperatively
Secondary outcomes:
measure: Postoperative pain
timeFrame: 4 h postoperatively
measure: Plasma concentration of lidocaine
timeFrame: 24 h
measure: Length of Hospital stay
timeFrame: 1-5 days
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Örebro University Hospital, Örebro, Sweden
name: Kjell Axelsson, MD, PhD
role: STUDY_DIRECTOR
References: