Acute Postoperative Pain Clinical Trial
Official title:
Ultrasound Guide Bilateral Erector Spinae Block Versus Caudal Epidural Analgesia for Perioperative Analgesia in Lumbar Spine Surgeries:Randomized Controlled Study
NCT number | NCT05351203 |
Other study ID # | MS-620-2021 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2022 |
Est. completion date | May 22, 2023 |
Verified date | September 2023 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Major lumbar spine surgeries are associated with severe postoperative pain that usually lasts for at least 3 days.Caudal epidural analgesia has a crucial role in providing effective pain relief post lumbar spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) as a new technique of trunk fascia block was proposed in 2016Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics. The aim of this work is to evaluate the pre-emptive analgesic effect of Ultrasound guided bilateral erector spinae block Vs Caudal epidural analgesia in Lumbar spine surgeries during peri-operative period. Objectives: - To assess the duration of analgesia in both groups and time to rescue analgesia . - To assess Visual analogue scale (VAS) score in both groups. - To assess complications of both groups
Status | Completed |
Enrollment | 50 |
Est. completion date | May 22, 2023 |
Est. primary completion date | September 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients undergoing Lumbar spine surgery (L1-L5). - American society of anesthesiologists classification (ASA) I and II. Exclusion Criteria: - Patient's refusal. - Bleeding disorders (platelets count < 150,000; International normalized ratio >1.5; PC< 60%) and coagulopathies. - Skin lesion, wounds or infection at the injection site. - Known allergy to local anesthetic drugs. - Chronic opioid or NSAIDS users. - Patients with pre-operative opioid consumption |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alainy Hospitals | Giza | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time to first analgesia request | postoperative first rescue analgesia time | 12 hours | |
Secondary | cumulative 24 hours opioid consumption | the total amount of opioid consumed by the patient in the first 24 hours postoperative | 24 hours | |
Secondary | presence of any complications | presence of any complications such as urine retention,vomiting ,respiratory depression | 24 hours | |
Secondary | Mean arterial blood pressure | intraoperative mean arterial blood pressure | evey 10 minutes intraoperative till end of surgery (up to 2 hours) | |
Secondary | Heart rate | intraoperative heart rate | every 10 minutes intraoperative till end of surgery(up to 2 hours) | |
Secondary | VAS score | The visual analog score (VAS) is a validated,subjective measure for acute and chronic pain.scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain" | at 15 & 30 mins, then at 2, 6, 12, 24 hours post-operatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05926817 -
Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery
|
N/A | |
Completed |
NCT05386095 -
Axillary Brachial Plexus Block Using 0.25% Bupivacaine Versus Using 0.19%Bupivacaine in Pediatrics
|
N/A | |
Completed |
NCT05364216 -
Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients
|
N/A | |
Completed |
NCT04875390 -
Erector Spina Plane (ESP) Block in Pediatric Patients
|
N/A | |
Recruiting |
NCT06381401 -
Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults
|
Phase 4 | |
Completed |
NCT05068037 -
Influence of Hypnoacupuncture on Early Perioperative Recovery
|
N/A | |
Completed |
NCT04169256 -
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of HYR-PB21 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04855240 -
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
|
Phase 2 | |
Recruiting |
NCT06381063 -
Non-steroidal Anti-inflammatory in Cardiac Surgery
|
N/A | |
Completed |
NCT02107339 -
Methadone and Hydromorphone For Spinal Surgery
|
Phase 4 | |
Recruiting |
NCT06281275 -
A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients
|
||
Not yet recruiting |
NCT06088602 -
Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty
|
N/A | |
Not yet recruiting |
NCT04775992 -
Preemptive Analgesia of Gabapentoids in Orthopedic Surgery
|
||
Active, not recruiting |
NCT05260008 -
Study Assessing Pain Relief After Replacement of the Knee
|
Phase 2 | |
Completed |
NCT01828424 -
Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery
|
||
Not yet recruiting |
NCT05865366 -
Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients
|
||
Recruiting |
NCT04033471 -
Combined Epidural Morphine and Midazolam on Postoperative Pain
|
Phase 1/Phase 2 | |
Completed |
NCT03903224 -
Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy
|
N/A | |
Completed |
NCT02115945 -
Femoral and Epidural Block After Total Knee Arthroplasty
|
Phase 0 | |
Completed |
NCT05096468 -
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
|
Phase 2/Phase 3 |