Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy

Not Applicable

• Conditions: Thoracic Epidural Analgesia; Erector Spinae Plane Block; Nephrectomy

• Registration Number: NCT04947644
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.

Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.

The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.

Detailed Description

The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra. Hence, LA is distributed in the cranio-caudal fascial plane. Additionally, it diffuses anteriorly to the paravertebral and epidural spaces, and laterally to the intercostal space at several levels.

Cadaveric studies was done on ESPB using MRI to evaluate the spread of local anesthetic mixed with gadolinium dye. Showed the spread of injected volume of 30 ml at level of T10 spread between the level of T5 and T12 . Other cadaveric study showed the spread of the dye to thoracic paravertebral space which may explain the visceral analgesic effect of the block.

There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.

Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.

The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.

Study Timeline

• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Study Start: 2021-07-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-14
• Primary Completion: 2022-05-14
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• American Society of Anesthesiologists class II.
• Patients undergoing open nephrectomy for malignant renal tumors.
• Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.

Exclusion Criteria

• Patient refusal.
• Local infection at the puncture site.
• Coagulopathies with platelet count below 50,000 or an international normalized ratio >1.6.
• Renal and hepatic insufficiency.
• Unstable cardiovascular disease.
• History of psychiatric and cognitive disorders.
• Patients allergic to medication used.
• Abnormal anatomy of the thoracic region.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total morphine consumption within 24 hours postoperative	First 24 hours postoperatively.	Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score \>3. The total amount of morphine given in 24 hours will be recorded for every patient.

Secondary Outcome Measures

Name	Time	Method
Changes in postoperative heart rate	First 24 hours postoperatively.	It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.
Total intra-operative fentanyl consumption.	Intra-operative	Elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg
The time of first rescue analgesia.	First 24 hours postoperatively.	Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score \>3
Pain using Numerical rating scale (NRS) at rest	First 24 hours postoperatively.	Pain scores using NRS will be recorded in the post anaesthesia care unit , and for the next 24 hours (1, 2, 4, 6, 12 and 24h) postoperatively. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain.
Changes in Intraoperative heart rate	Intraoperatively	It will be recorded before injection of the local anesthetics to be defined as a baseline reading and follow up after injection then will be recorded immediately before and after surgical incision and at 30 min intervals intraoperatively.
Total dose of bupivacaine consumption.	First 24 hours postoperatively.	In thoracic epidural analgesia group 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given.; In erector spinae plane block group 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given.; In both groups: Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
Pain using Numerical rating scale (NRS) during movement	First 24 hours postoperatively.	Pain scores using NRS will be recorded in the post anaesthesia care unit , and for the next 24 hours (1, 2, 4, 6, 12 and 24h) postoperatively. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain.
Changes in postoperative mean arterial blood pressure	First 24 hours postoperatively.	It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.
The incidence of various side effects .	Intra-operative and first 24 hours postoperatively.	such as hemodynamic instability, nausea, vomiting, dural puncture with the needle or the catheter, post dural puncture headache, failed block, unintentional intravascular injection of local anesthetic, local anesthetic toxicity and respiratory depression (respiratory rate \<10/minute) will be recorded
Changes in Intraoperative mean arterial pressure	Intraoperatively	It will be recorded before injection of the local anesthetics to be defined as a baseline reading and follow up after injection then will be recorded immediately before and after surgical incision and at 30 min intervals intraoperatively.

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt