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

NCT ID: NCT04947644

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-06-15

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.

Conditions

Erector Spinae Plane Block; Thoracic Epidural Analgesia; Nephrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thoracic epidural analgesia group

After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. 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

Group Type: ACTIVE_COMPARATOR

Thoracic epidural analgesia

Intervention Type: PROCEDURE

After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. 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

Ultrasound guided continuous erector spinae plane block group

After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 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, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. 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

Group Type: EXPERIMENTAL

Ultrasound guided continuous erector spinae plane block

Intervention Type: PROCEDURE

After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 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, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. 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

Interventions

Thoracic epidural analgesia

After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. 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

Intervention Type: PROCEDURE

Ultrasound guided continuous erector spinae plane block

After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 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, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud Abd elgalil, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer of Anesthesia ,Pain Relief and ICU National Cancer Institute ,Cairo University

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud Abd elgalil, MD

Role: CONTACT

dr.ma7moud-abdelgilil@yahoo.com

00201285332068

Facility Contacts

Atef Badran, MD

Role: primary

irb@nci.cu.edu.eg

+(202) 2532 82 86

Other Identifiers

2015-301-015

Identifier Type: -

Identifier Source: org_study_id