Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.
Condition: Uterine Myoma; Persistent Post-menpausal Bleeding; Uterine Cancer
MeSH terms: Uterine Neoplasms; Leiomyoma; Myofibroma; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Normal saline; Intravenous Lidocaine; Intra-abdominal Lidocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Normal saline would be administered intravenously and intra-abdominally.; Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.; 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 intervention name(s): Xylocaine 5 mg/ml; Xylocaine 5 mg/ml
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Surgery: Abdominal hysterectomy; Anesthetics: Local; Postoperative: Pain; Drugs: Morphine