Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopic Hysterectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
Overview
- Phase
- Phase 1
- Intervention
- Bupivacaine
- Conditions
- Pain, Postoperative
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Postoperative Pain Score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Matthew Davies
Professor, Division of Urogynecology and Minimally Invasive GYN Surgery
Milton S. Hershey Medical Center
Eligibility Criteria
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.
Arms & Interventions
Bupivacaine
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.
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Postoperative Pain Score
Time Frame: 24 hours
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".
Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)
Time Frame: 4 hours
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".
Secondary Outcomes
- Estimated Blood Loss > 200 mL(day of surgery after procedure completion)
- Surgical Complications(From date of randomization up to 12 months)
- Length of Hospital Stay >= 24 Hours(from time surgery completed to time patient discharged)
- Operating Time(start to end of patient's surgery)
- Histopathologic Diagnosis(Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.)