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Preemptive Analgesia for Post Abdominal Hysterectomy Pain Management

35 Years
58 Years
Not Enrolling

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Trial Information

Preemptive Analgesia for Post Abdominal Hysterectomy Pain Management

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.

Inclusion Criteria:

- Women who are scheduled for abdominal hysterectomy because of myomatous uterus via
lower transverse incision.

Exclusion Criteria:

- Oncological disease

- Systemic vascular disease

- Neurological disease

- Diabetes

- More than two previous abdominal surgeries.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Postoperative pain scores: they were significantly lower in the study group in the first postoperative 8 hours

Principal Investigator

Peter Jakobi, MD

Investigator Role:

Study Director

Investigator Affiliation:

Department of OBGYN, Rambam Medical Center, Technion the Bruce Rappaort Faculty of Medicine


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

November 2002

Completion Date:

September 2003

Related Keywords:

  • Pain
  • Pain
  • Hysterectomy
  • Preemptive
  • Lidocaine