Post-operative Pain Clinical Trial
Official title:
Ultrasound Guided Posterior Quadratus Lumborum Block for Improved Postoperative Analgesia in Minimally Invasive Gynecologic Surgery
NCT number | NCT04549090 |
Other study ID # | 2020-02-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | April 5, 2022 |
Verified date | April 2022 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The challenge to achieve adequate analgesia has led to the development of directed, multi-modal protocols specific to management of post-laparoscopy pain in effort to decrease the amount of additional administration of narcotic medication. While several non-opioid regiments have been found to be effective, opioid medications still play a significant role in early postoperative analgesia. Given the adverse side effects of narcotic medications, regional blocks utilizing local anesthetic agents and has been shown to improve overall pain control in this time period. Truncal abdominal nerve blocks are useful for pain control in abdominal and pelvic surgeries. More recently, the utilization of the quadratus lumborum (QL) block has effectively alleviated somatic and visceral pain in the upper and lower abdomen. The QL block provides analgesia spanning from the T4 to L1 dermatomal levels in the thoracolumbar plane to provide a broad sensory level analgesic effect. The approach involves injecting local anesthetic under ultrasound guidance into the plane posterior to the quadratus lumborum muscle and middle layer of thoracolumbar fascia. Given the utility of the QL block in controlling somatic pain, this study aims to determine whether the QL block is an effective analgesic adjunct in the control of postoperative pain period, specifically with regards to patients undergoing laparoscopic gynecologic surgery.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 5, 2022 |
Est. primary completion date | April 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients will be eligible for recruitment if between the ages of 18 to 65 scheduled to undergo laparoscopic or robotic total or supracervical hysterectomy for benign indications. Only surgery for benign pathology will be considered to enrollment. No Malignancy cases will be included. Exclusion Criteria: - 1. History of adverse reaction or allergy to Bupivacaine or liposomal bupivacaine 2. Medical contraindication to placement of QL block. 3. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue. 4. Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating. 5. Any clinically significant condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course. 6. Pregnant patients 7. Less than 40Kg weight. |
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Pedram Bral |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in pain score | Our primary outcome is difference in pain scores at 3 hours between the two groups. The pain score will be assessed using Numeric Rating Scale (NRS) from 0-10 with 0 as no pain and 10 as worst possible pain | 3 hours postoperative | |
Secondary | Difference in pain score | Our secondary outcome is difference in pain scores at 1 hour between the two groups. The pain score will be assessed using Numeric Rating Scale (NRS) from 0-10 with 0 as no pain and 10 as worst possible pain | 1 hour postoperative | |
Secondary | Difference in pain score | Our secondary outcome is difference in pain scores at 24 hour between the two groups. The pain score will be assessed using Numeric Rating Scale (NRS) from 0-10 with 0 as no pain and 10 as worst possible pain | 24 hours postoperative | |
Secondary | Difference in amount of pain killers used | Our secondary outcome is difference in the amount of pain killers used during the 24 hour period post operatively | pain killers used during the 24 hours postoperatively. The patient will be provided an empty sheet to record everytime a pain killer is used including the type and dose of pain killer . The pain killers are prescribed at the surgeon's discretion |
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