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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.


Phase 4
30 Years
75 Years
Open (Enrolling)
Female
Uterine Myoma, Persistent Post-menpausal Bleeding, Uterine Cancer

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Morphine consumption

Outcome Description:

Total rescue morphine consumption during 0 - 24 h would be the primary endpoint

Outcome Time Frame:

0 - 24 h postoperatively

Safety Issue:

No

Principal Investigator

Kjell Axelsson, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Örebro University Hospital, Örebro, Sweden

Authority:

Institutional Review Board, Sweden:

Study ID:

20111212

NCT ID:

NCT01492179

Start Date:

November 2011

Completion Date:

December 2012

Related Keywords:

  • Uterine Myoma
  • Persistent Post-menpausal Bleeding
  • Uterine Cancer
  • Surgery: Abdominal hysterectomy
  • Anesthetics: Local
  • Postoperative: Pain
  • Drugs: Morphine
  • Hemorrhage
  • Myoma
  • Pain, Postoperative
  • Leiomyoma
  • Myofibroma
  • Uterine Neoplasms

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