Post-Operative Pain After Laparoscopic Ventral Hernia Repair, Impact of Mesh Impregnation With Bupivacaine Solution vs. Normal Saline Solution
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-Operative Pain will be graded on visual analogue scale (VAS)
研究概览
简要总结
Early post-operative pain and discomfort after laparoscopic repair remains a concern for patients requiring hospital stay and parenteral narcotic analgesics . This quite often proves to be a hindrance in early ambulation, enhances patient discomfort and prevents early discharge from hospital.
Local anesthetics infiltration at wound site after various procedures is known to be effective in reducing immediate post-operative pain , . In case of laparoscopic ventral hernia repair, delivering local anesthetic at site of mesh application can be achieved by soaking the mesh in local anesthetic solution before application. To date there is no evidence regarding impact of soaking mesh in bupivacaine solution before application in case of laparoscopic ventral hernia repair.
OBJECTIVE:
Primary Objective:
To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to normal saline solution on post-operative pain after laparoscopic ventral hernia repair.
Secondary Objective:
To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to saline solution on length of hospital stay after laparoscopic ventral hernia repair.
Study Sample:
Patients with uncomplicated ventral abdominal wall hernia presenting at general surgery clinics of AKUH Karachi who are planned to undergo laparoscopic repair and meet eligibility criteria of inclusion into trial.
SETTINGS:
Study will be conducted in General Surgery Section of Aga Khan University Hospital, Karachi.
Patients will be evaluated in clinic at the time of presentation regarding eligibility to participate in study. Written informed consent will be taken in clinic. A copy of the consent form will be handed over to the patient. Clinical Trial Unit will be informed of the scheduled date and time of the operation. Allocation will be done by the staff at clinical trial unit which will be kept undisclosed to the investigators, patients and outcome assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form according to treatment arm allocation. After the operation first assessment of pain will be done six hours post-operatively using VAS. Second assessment will be done at twenty four hours from end of operation. This assessment will be done directly if patient is admitted in the hospital or will be done on telephone if patient is discharged home.
FOLLOW UP:
Pain assessment will be done using visual analogue scale (VAS). This is validated score to measure level of pain. It ranges from zero to ten. Score of 0 means no pain and score of ten means worst pain one can ever have. Score will be assessed at 6 and 24 hours from procedure.
详细描述
INTRODUCTION:
Laparoscopic approach to uncomplicated ventral hernia repair as compared to open repair has advantages of less post operative pain, less rates of wound infection , , early recovery, shortened hospital stay and less overall cost of treatment , , . Patient satisfaction after laparoscopic procedure is better as compared to open repair . Recurrence rate is also known to be less in laparoscopic repair as compared to open repair. Despite all this, laparoscopic approach is utilized in only about quarter of patients with ventral hernia in developed countries , . Early post-operative pain and discomfort after laparoscopic repair remains a concern for patients requiring hospital stay and parenteral narcotic analgesics . Intensity of pain is similar regardless of method of fixation of mesh. This quite often proves to be a hindrance in early ambulation, enhances patient discomfort and prevents early discharge from hospital. Early post-operative pain is thought to be secondary to dissection in the area of mesh application. Local application of anesthetic agent is this area can potentially overcome this problem and make the procedure feasible as an ambulatory care operation.
Local anesthetics infiltration at wound site after various procedures is known to be effective in reducing immediate post-operative pain , . In case of laparoscopic ventral hernia repair, delivering local anesthetic at site of mesh application can be achieved by soaking the mesh in local anesthetic solution before application. Bupivacaine is long acting local anesthetic. Results of studies that have used this class of drugs intra-peritonealy in other types of surgeries for analgesic purpose have shown it to be safe for intra-operative use. To date there is no evidence regarding impact of soaking mesh in bupivacaine solution before application in case of laparoscopic ventral hernia repair. These patients require post operative intravenous analgesic agents to deal with early post operative pain.
If this turns out to be effective intervention, it will improve patient satisfaction and early discharge from hospital. This can also potentially reduce cost of care.
OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation will be done by the staff at clinical trial unit which will be kept undisclosed to the investigators, patients and outcome assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form according to treatment arm allocation.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of age > 16 Years
- •Both males and females
- •Ventral Abdominal Wall Hernial Defect planned to undergo laparoscopic repair.
- •Ventral Abdominal Wall Hernia is defined as defect in anterior abdominal wall through which contents of abdominal cavity can protrude. Anterior abdominal wall extends from Xiphisternum above to symphysis pubis below and anterior axillary lines laterally.
- •We plan to include both primary and incisional hernias in our study.
排除标准
- •Complicated Ventral Abdominal Wall Hernia (Strangulated, Obstructed)
- •Recurrent Hernias
- •Renal Insufficiency: Serum Creatinine > 1.5
- •Hepatic Insufficiency: Known case of chronic liver disease or Total Bilirubin > 2mg/dl
- •Pregnant or lactating Females
- •Emergency Operations
- •Current or regular use of analgesics for some other indication
- •Patients with known hypersensitivity to the study drug.
- •Refusal to Informed Consent
- •Simultaneous additional surgical procedures
研究组 & 干预措施
Controlled Arm
Mesh will be soaked in normal saline solution as is routinely done.
干预措施: Saline (Other)
Intervention Arm
Mesh will be soaked in .5% bupivacaine solution before application.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Post-Operative Pain will be graded on visual analogue scale (VAS)
时间窗: Scale will be presented to the participant at 6 hours post procedure.
Post-operative pain will be assessed by trained staff. Pain will be graded on visual analogue scale (VAS). VAS is validated scoring system according to which intensity of pain is scored on a scale of 0 to 10, 0 being no pain and 10 being worst pain.
Post-Operative Pain
时间窗: Scale will be presented to the participant at 24 hours post procedure.
Post-operative pain will be assessed by trained staff. Pain will be graded on visual analogue scale (VAS). VAS is validated scoring system according to which intensity of pain is scored on a scale of 0 to 10, 0 being no pain and 10 being worst pain.
次要结局
- Length of hospital stay(Upto a maximum of 30 days from procedure)