Preemptive Analgesia for Abdominal Hysterectomy

NCT00121498 | Completed

• 1 other identifier: 1571CTIL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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 .

Conditions

Pain

Keywords

Pain; Hysterectomy; Preemptive; Lidocaine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• No significant differences between the groups were noted in analgesic consumption on the second post- operative day

Interventions

Lidocaine (local anesthetics) 20 ml of 1 % subcutaneously DRUG

Eligibility Criteria

• Age: 35 Years - 58 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Oncological disease
• Systemic vascular disease
• Neurological disease
• Diabetes
• More than two previous abdominal surgeries.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (2)

Dept. OBGYN, Rambam Medical Center

Haifa, 9602, Israel

Location

Rambam Medical Center, Dept OBGYN

Haifa, 9602, Israel

Location

Related 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. doi: 10.1093/bja/80.2.245.

  PMID: 9602595 RESULT

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Peter Jakobi, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2005
• First Posted: July 21, 2005
• Study Start: November 1, 2002
• Study Completion: September 1, 2003
• Last Updated: September 14, 2005

Record last verified: 2004-12

Locations

IL (2)