Preemptive Analgesia for Abdominal Hysterectomy

Pain Clinical Trial

Official title:

Preemptive Analgesia for Post Abdominal Hysterectomy Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121498
• Other study ID #: 1571CTIL
• Status: Completed
• Phase: N/A
• First received: July 13, 2005
• Last updated: September 12, 2005
• Start date: November 2002
• Est. completion date: September 2003

Study information

• Verified date: December 2004
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 58 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine (local anesthetics) 20 ml of 1 % subcutaneously

Locations

Country	Name	City	State
Israel	Dept. OBGYN, Rambam Medical Center	Haifa
Israel	Rambam Medical Center, Dept OBGYN	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Ali PB, Cotton BR, Williamson KM, Smith G. Intraperitoneal bupivacaine or lidocaine does not provide analgesia after total abdominal hysterectomy. Br J Anaesth. 1998 Feb;80(2):245-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores: they were significantly lower in the study group in the first postoperative 8 hours
Secondary	No significant differences between the groups were noted in analgesic consumption on the second post- operative day