Ultrasound Guided Posterior Quadratus Lumborum Block for Postoperative Analgesia in Gynecologic Surgery

NCT04549090 | Completed FDA Drug

• 1 other identifier: 2020-02-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-operative Pain; Gynecologic Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference in pain score

  1 hour postoperative

• Difference in pain score

  24 hours postoperative

• Difference in amount of pain killers used

  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

Study Arms (2)

No QL block group

These patients will not be receiving QL block based on their shared decision with their surgeon and anesthesiologist. Patients' pain scores and amount of pain killers will be followed up for 24 hours postoperatively

QL block group

These patients will be receiving QL block based on their shared decision with their surgeon and anesthesiologist. Patients' pain scores and amount of pain killers will be followed up for 24 hours postoperatively

Drug: QL (quadratus lumborum) block administration

Interventions

QL (quadratus lumborum) block administration DRUG

Fo the QL block group, they will be receiving bilateral QL block. A total of 40ml of 0.25% bupivacaine (Marcaine) and 10ml of liposomal bupivacaine (Exparel) will be administered

QL block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients between the ages of 18 to 65 scheduled to undergo laparoscopic or robotic total or supracervical hysterectomy for benign indications

You may qualify if:

• 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.

You may not qualify if:

• \. History of adverse reaction or allergy to Bupivacaine or liposomal bupivacaine
• \. Medical contraindication to placement of QL block.
• \. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
• \. 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.
• \. 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.
• \. Pregnant patients
• \. Less than 40Kg weight.

Sponsors & Collaborators

• Pedram Bral: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Pedram Bral, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

US (1)