Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy

Study Overview
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Brief Summary
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The primary objective of this study is to assess if injection of local anesthetic to the laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain after surgery.

Detailed Description
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The growing interest in minimally invasive gynecologic surgeries have increased the number of patients undergoing laparoscopic hysterectomies. Although many patients are being discharged home the same day of surgery, majority of patients complain of immediate postoperative pain after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves over a short period of time, infiltration of local anesthetic to trocar insertion sites might alleviate the patient's discomfort during the recovery period. Immediate post-operative pain relief further facilitates early discharge and faster patient recovery. Published data regarding the effects of preemptive port site local anesthesia in gynecologic operative laparoscopy have been limited and controversial. Visceral pain control through afferent nerve block could minimize pain perception especially during the first postoperative hours. This study aims to assess the influence of infiltration of local anesthetic to trocar insertion sites after laparoscopic hysterectomy on postoperative pain.

Official Title
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Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopic Hysterectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are scheduled for a laparoscopic hysterectomy for benign indications at the Department of Obstetrics & Gynecology's Division of Minimally Invasive Surgery at Milton S. Hershey Medical Center will be included. Exclusion Criteria: Patients who are scheduled for a hysterectomy through the vaginal or abdominal approach will be excluded. Patients with preoperative indications of endometriosis or chronic pelvic pain will also be excluded since these patients could potentially have higher thresholds of pain.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Treatment<br>The No Treatment group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine. | |
| Active Comparator: Bupivacaine<br>The Bupivacaine Arm includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. | Drug: Bupivacaine<br>* Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS) | Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move. | 4 hours | 
| Postoperative Pain Score | Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move. | 6 hours | 
| Postoperative Pain Score | Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss > 200 mL | Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as >200 mL vs. <= 200 mL. | day of surgery after procedure completion | 
| Surgical Complications | Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation. | From date of randomization up to 12 months | 
| Operating Time | Operating time measured in minutes | start to end of patient's surgery | 
| Length of Hospital Stay >= 24 Hours | Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours. | from time surgery completed to time patient discharged | 
| Histopathologic Diagnosis | Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other. | Histopathologic diagnosis will be measured on the day of surgery after completing the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local, Anesthesia, Pain, Laparoscopic hysterectomy, Trocar site, Port site