- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00121498
Preemptive Analgesia for Abdominal Hysterectomy
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.
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 .
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel, 9602
- Dept. OBGYN, Rambam Medical Center
-
Haifa, Israel, 9602
- Rambam Medical Center, Dept OBGYN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Postoperative pain scores: they were significantly lower in the study group in the first postoperative 8 hours
|
Secondary Outcome Measures
Outcome Measure |
---|
No significant differences between the groups were noted in analgesic consumption on the second post- operative day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Peter Jakobi, MD, Department of OBGYN, Rambam Medical Center, Technion the Bruce Rappaort Faculty of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Membrane Transport Modulators
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anesthetics
- Lidocaine
- Anesthetics, Local
Other Study ID Numbers
- 1571CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Lidocaine (local anesthetics) 20 ml of 1 % subcutaneously
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedNeedlestick InjuriesNorway
-
Hospital for Special Surgery, New YorkCompletedInterscalene Block | Shoulder ArthroscopyUnited States
-
Chisel Peak Medical ClinicK. Dean Reeves, M.D.CompletedTemporomandibular Joint DisordersCanada
-
Frusso, Ricardo, M.D.Zarate, Miguel, M.D.CompletedTemporomandibular Joint DisordersArgentina
-
Allina Health SystemCompletedPain | Local Anesthesia for Peripheral Intravenous CatheterizationUnited States
-
The Baruch Padeh Medical Center, PoriyaUnknown
-
Hospices Civils de LyonRecruitingNeuropathic Pain | Complex Regional Pain Syndrome Type 1France
-
Lundbeck FoundationCompletedPostoperative Pain | Analgesic EfficacyDenmark
-
Pontificia Universidad Catolica de ChileUnknown
-
Baylor College of MedicineWithdrawn