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

NCT04947644 | Unknown

• 1 other identifier: 2015-301-015
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Erector Spinae Plane Block; Thoracic Epidural Analgesia; Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption within 24 hours postoperative

  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.

  First 24 hours postoperatively.

Secondary Outcomes (10)

• Total intra-operative fentanyl consumption.

  Intra-operative

• The time of first rescue analgesia.

  First 24 hours postoperatively.

• Pain using Numerical rating scale (NRS) at rest

  First 24 hours postoperatively.

• Pain using Numerical rating scale (NRS) during movement

  First 24 hours postoperatively.

• Changes in Intraoperative heart rate

  Intraoperatively

Study Arms (2)

Thoracic epidural analgesia group

ACTIVE COMPARATOR

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

Procedure: Thoracic epidural analgesia

Ultrasound guided continuous erector spinae plane block group

EXPERIMENTAL

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

Procedure: Ultrasound guided continuous erector spinae plane block

Interventions

Thoracic epidural analgesia 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

Thoracic epidural analgesia group

Ultrasound guided continuous erector spinae plane block 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

Ultrasound guided continuous erector spinae plane block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mahmoud Abd elgalil, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Abd elgalil, MD

CONTACT

00201285332068; dr.ma7moud-abdelgilil@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: July 15, 2021
• Primary Completion: May 14, 2022
• Study Completion: June 15, 2022
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: one year from after the end of the study.

Locations

EG (1)