Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121498
Status:
COMPLETED
Last Update Posted:
2005-09-14
First Post:
2005-07-13
Brief Title:
Preemptive Analgesia for Abdominal Hysterectomy
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Preemptive Analgesia for Post Abdominal Hysterectomy Pain Management
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None