- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04361383
Erector Spinae Plane Versus Quadratus Lumborum Block for Patient Undergoing Open Nephrectomy
Ultrasound-Guided Erector Spinae Plane Versus Quadratus Lumborum Block For Postoperative Analgesia for Patient Undergoing Open Nephrectomy: A Randomized Controlled Study.
The postoperative pain after open nephrectomy remains a major concern because some patients still demonstrate acute pain that may develop chronic pain that lasts for months following the surgery.
Epidural analgesia is the gold standard for abdominal surgery including for open nephrectomy, however, it has unfavorable side effects such as paresthesia, hypotension, hematomas, an impaired motor of lower limbs and urinary retention that could delay recovery.
Various techniques have tried to replicate the analgesic efficacy of epidural analgesia. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and transmuscular quadratus lumborum (TQL) analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries.
Up to the investigator's knowledge, there is no study done to compare ESPB versus QLB as pre-emptive analgesia in patients undergoing open nephrectomy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Open surgery remains basic surgery for patients requiring radical or partial nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery [1]. The physiopathology of acute pain is explained as it is mediated by inflammatory cell infiltration, activation of the pain pathways in the spinal cord, and also reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery [2].
Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction [3].
Erector Spinae Plane block (RSPB), first described by Forero et al.,[4] for analgesia in thoracic neuropathic pain, has also been reported for the management of other causes of acute and postoperative pain [5,6,7]. In this ultrasound-guided (USG) technique, a local anesthetic (LA) is applied between the erector spinae muscle and the transverse process of the thoracic vertebra leading to the spread of LA cephalad, caudally and through the paravertebral space [4,5,8].
Quadratus Lumborum block (QLB) was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the LA was injected at the anterolateral aspect of the QL muscle (type 1 QLB) [9]. Later, J. Børglum used the posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type 3 QLB) [10]. Recently, R. Blanco described another approach by injecting the LA at the posterior aspect of the QL muscle (type 2 QLB), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is less [11]. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle [12].
The investigators hypothesize that performing ultrasound-guided ESPB block will be more superior to or equal to QLB in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Elsharqya
-
Zagazig, Elsharqya, Egypt, 44519
- Faculty of medicine, Zagazig University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient acceptance.
- BMI ≤ 30 kg/m2
- ASA II and III.
- Elective open nephrectomy under general anesthesia
Exclusion Criteria:
- History of allergy to the LA agents used in this study,
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control group
patients will be operated under general anesthesia.
|
the patient will receive general anesthesia
|
ACTIVE_COMPARATOR: QLB group
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
|
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
|
ACTIVE_COMPARATOR: ESPB group
patients will receive ultrasound-guided erector spinae plane block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
|
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 1st time to rescue analgesic
Time Frame: recorded within the first 24 hour postoperatively
|
the time to ask for postoperative analgesia is the time from the end of operation to patient reporting VAS ≥ 3.
|
recorded within the first 24 hour postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale (VAS)
Time Frame: measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively
|
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
|
measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively
|
Total dose of rescue analgesia (morphine)
Time Frame: in the first 24 hour postoperatively.
|
once the VAS score will be ≥ 3, rescue analgesia in the form of 0.1 mg/kg morphine will be given and the total dose consumed will be recorded
|
in the first 24 hour postoperatively.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.
- McCrum CL, Ben-David B, Shin JJ, Wright VJ. Quadratus lumborum block provides improved immediate postoperative analgesia and decreased opioid use compared with a multimodal pain regimen following hip arthroscopy. J Hip Preserv Surg. 2018 Oct 25;5(3):233-239. doi: 10.1093/jhps/hny024. eCollection 2018 Aug.
- Niraj G, Tariq Z. Continuous Erector Spinae Plane (ESP) Analgesia In Different Open Abdominal Surgical Procedures: A Case Series. (2018) J Anesth Surg 5(1): 57- 60.
- Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6004-12-4-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Disease
-
Novartis PharmaceuticalsCompletedEnd-Stage Renal Disease | Renal Failure, ChronicGermany
-
Ottawa Hospital Research InstituteHeart and Stroke Foundation of OntarioCompletedEnd-stage Renal Disease (ESRD) | Kidney DiseaseCanada
-
Cubist Pharmaceuticals LLCCompletedEnd-stage Renal Disease | Renal Failure Chronic Requiring HemodialysisUnited States
-
University of MichiganGilead SciencesCompletedCardiovascular Disease | End-stage Renal DiseaseUnited States
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...Changhai Hospital; Shanghai Zhongshan Hospital; RenJi Hospital; Ruijin Hospital; Shanghai... and other collaboratorsCompleted
-
Clinical Research Center for End Stage Renal Disease...Kyungpook National University Hospital; Medical Research Collaborating Center... and other collaboratorsActive, not recruitingEnd-Stage Renal DiseaseKorea, Republic of
-
Medtronic - MITGCompletedEnd-stage Renal DiseaseGermany
-
China Medical University HospitalUnknown
-
Guangdong Provincial Hospital of Traditional Chinese...Ministry of Science and Technology of the People´s Republic of ChinaUnknown
Clinical Trials on control group
-
Tasly Pharmaceutical Group Co., LtdCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Henan Cancer HospitalRecruitingChemotherapy | Immune Checkpoint Inhibitor | Locally Advanced Gastric CarcinomaChina
-
International University of La RiojaRecruiting
-
The University of Hong Konghong Kong Cancer FundCompletedBreast Cancer | Yoga Therapy | Shoulder Joint Motion | Scar Contracture
-
Romanian Society of Anesthesia and Intensive CareUniversity of Medicine and Pharmacy "Victor Babes" Timisoara; Timişoara County...Completed
-
Physicians Committee for Responsible MedicineMetropolitan Police Department of Washington, D.C.SuspendedDiabetes Mellitus, Type 2 | Overweight | Blood PressureUnited States
-
University of PernambucoUnknown
-
Yonsei UniversityUnknownAdvanced Gastric Cancer | Neoadjuvant Chemotherapy | Palliative ChemotherapyKorea, Republic of
-
Beijing Tiantan HospitalNot yet recruitingIschemic Stroke | Post-stroke Cognitive Impairment