The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

NCT ID: NCT05480111

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2023-04-07

Brief Summary

The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

QL Block

Group Type: EXPERIMENTAL

Sham Local

Intervention Type: DRUG

20 mls of normal saline given at incision site

QL

Intervention Type: DRUG

QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

Local Anesthesia at incision site

Group Type: ACTIVE_COMPARATOR

Local anesthesia at incision site

Intervention Type: DRUG

20 ml of 0.25% Bupivacaine will be given at incision site

Sham QL

Intervention Type: DRUG

20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

Interventions

Local anesthesia at incision site

20 ml of 0.25% Bupivacaine will be given at incision site

Intervention Type: DRUG

Sham QL

20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

Intervention Type: DRUG

Sham Local

20 mls of normal saline given at incision site

Intervention Type: DRUG

QL

QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• English or Spanish speaking
• American Society of Anesthesiologists (ASA) physical status 1-3
• Planned laparoscopic or robotic hysterectomy

Exclusion Criteria

• History of chronic pain requiring preoperative opioids, Known alcoholism disorder
• Congenital coagulopathy,
• Localized soft tissue infection,
• Use of anticoagulants,
• Dementia, inability or refusal to provide consent for the surgery
• Morbid obesity (BMI > 50), due to expected technical difficulty to achieve the block

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Randa Jalloul

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randa J Jalloul, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-22-0158

Identifier Type: -

Identifier Source: org_study_id