Preemptive Analgesia for Abdominal Hysterectomy
Condition: Pain
Study type: Interventional

Summary: 
      Preemptive analgesia is defined as "analgesic intervention provided before surgery to prevent
      or reduce subsequent pain". By preventing central sensitization using nociceptive blockers by
      regional analgesia we may able to produce a painless postsurgical state. The use of
      preemptive analgesia was reported in various surgical procedures, such as in limb surgeries,
      laparoscopic procedures, mastectomy and vaginal hysterectomy. Regarding abdominal
      hysterectomy there are only few reports, however both, malignancies and benign cases were
      included and conflicting results were obtained regarding the value of preemptive analgesia.
      Since hysterectomy is the most frequent major surgical procedure performed in gynecology, and
      it is estimated that by age 64 years, 40 % of women will have had a hysterectomy, it would be
      of great value to optimize pain treatment in these patients.

      The aim of the present study was to evaluate the effectiveness of preemptive analgesia in
      women who undergo a transabdominal hysterectomy for benign uterine abnormalities.

      Hypothesis: Lidocaine (5%) injection to the scar area before incision is effective in pain
      reduction among women who undergo a transabdominal hysterectomy for benign uterine
      abnormalities .
    

Detailed description: 
      Preemptive analgesia is defined as "analgesic intervention provided before surgery to prevent
      or reduce subsequent pain". By preventing central sensitization using nociceptive blockers by
      regional analgesia we may able to produce a painless postsurgical state. The use of
      preemptive analgesia was reported in various surgical procedures, such as in limb surgeries,
      laparoscopic procedures, mastectomy and vaginal hysterectomy. Regarding abdominal
      hysterectomy there are only few reports, however both, malignancies and benign cases were
      included and conflicting results were obtained regarding the value of preemptive analgesia.
      Since hysterectomy is the most frequent major surgical procedure performed in gynecology, and
      it is estimated that by age 64 years, 40 % of women will have had a hysterectomy, it would be
      of great value to optimize pain treatment in these patients.

      The aim of the present study was to evaluate the effectiveness of preemptive analgesia in
      women who undergo a transabdominal hysterectomy for benign uterine abnormalities.

      Material and Methods:

      The study was approved by the Institutional Review Board in accordance with the Helsinki
      declaration. Rambam Medical Center is a public hospital, with no private patients and women
      are treated according to the same standard of guidelines. Women with a benign uterine myoma
      with or without menometrorrhagia are considered for the study. Patients are excluded if they
      have a systemic vascular or neurological disease, diabetes or more than two previous
      abdominal surgeries. A written informed consent, is obtained from the patients prior to
      randomization into two treatment groups. In the first group 20 ml of 1 % lidocaine were
      injected subcutaneously in the incisional region 15 minutes prior to the start of operation.
      In the second group 20 ml of normal saline are injected subcutaneously in the incisional area
      15 minutes prior to operation. The syringes containing Lidocaine or Saline solution are
      prepared and coded by the pharmacist of the hospital. The surgeons, anesthetists and the
      nursing staff are all blinded to the type of solution, which is injected. The code is
      disclosed only at the end of the study. The anesthetic technique is standardized. A
      transverse lower abdominal incision is used in all patients. After completion of operation
      all patients are treated in the postoperative care unit for two hours. The time of arrival in
      the postoperative care unit is defined as time zero. Analgesia with morphine and pethidine
      was provided only on patient request. Thereafter patients are transferred to the
      Gynecological department.

      The standard care for postoperative pain in our department is as follows: three fixed doses
      of Ibuprofen 400 mg at three hour intervals with the first dose administrated at arrival to
      the department (2 hours after operation). Women are informed, that they can receive a rescue
      dose of another medication for breakthrough pain if further analgesia is needed before the
      three hours elapses. In such cases they receive an intramuscular injection of 10 mg morphine.
      After completion of the fixed interval analgesic regimen, patients are allowed to receive
      four more doses of oral analgesics upon their request at 3-hour intervals. Starting from the
      second postoperative day, only oral analgesia is provided, on patient request. Pain intensity
      is evaluated in the first 24 postoperative hours, before the administration of each dose of
      analgesic medication. The self-report of pain is assessed by measurement on a 100 mm Visual
      Analogue Scale (VAS), ranging from "No Pain" (0), to "The most pain imaginable" (100).
      Patients are instructed to place a mark on the line that indicates the level of pain
      experienced. In addition, overall satisfaction with post surgical pain treatment was
      evaluated by patients 72 hours after surgery, with use of the same visual analogue scale but
      with phrasing of "very satisfactory" and "not satisfactory at all" The VAS results during the
      24 hours and the number of doses of analgesia consumption during hospitalization will be
      compared between two groups using x test.
    

Intervention name(s): Lidocaine (local anesthetics) 20 ml of 1 % subcutaneously
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Pain; Hysterectomy; Preemptive; Lidocaine