Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Open Subcostal Renal Surgeries

NCT07012590 | Completed

• 1 other identifier: KFSIRB200-525
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the analgesic efficacy between morphine and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided erector spinae plane block for open subcostal renal surgeries.

Conditions

Morphine; Dexmedetomidine; Adjuvants; Bupivacaine; Ultrasound; Erector Spinae Plane Block; Open Subcostal Renal Surgeries

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  The degree of pain was assessed using the Visual analogue scale (VAS) \[where (0 = no pain and 10 = severe pain)\]. VAS was evaluated at 0, 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.

  24 hours postoperatively

Secondary Outcomes (5)

• Duration of sensory block

  Intraoperatively

• Time to first rescue analgesia

  48 hours postoperatively

• Total opioid consumption

  48 hours postoperatively

• Heart rate

  48 hours postoperatively

• Mean arterial pressure

  48 hours postoperatively

Study Arms (3)

Morphine group

EXPERIMENTAL

Patients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%.

Drug: Morphine

Dexmedetomidine group

EXPERIMENTAL

Patients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%.

Drug: Dexmedetomidine

Control group

ACTIVE COMPARATOR

Patients received erector spinae plane block with bupivacaine 30 ml 0.25% only.

Other: Erector spinae plane block

Interventions

Morphine DRUG

Patients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%.

Morphine group

Dexmedetomidine DRUG

Patients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%.

Dexmedetomidine group

Erector spinae plane block OTHER

Patients received erector spinae plane block with bupivacaine 30 ml 0.25% only.

Control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's approval.
• Age: 20 - 65 years.
• Physical Status: American Society of Anesthesiologists (ASA) I \& II.
• Patients undergoing open subcostal renal surgeries.

You may not qualify if:

• Patient refusal.
• Age: \>65 and \<20 years.
• Allergy to Dexmedetomidine, local anesthetics, systemic opioids, and any of the drugs included in the multimodal perioperative pain protocol.
• Patient with coagulation disorders.
• Chronic pain syndromes and patients with chronic opioid use are defined as use of regular daily doses of systemic narcotics for the past 6 months before the surgery.
• Body mass index of 35 kg/ m2 or more.
• Physical Status: American Society of Anesthesiologists (ASA) III \& IV.
• Local infection or sepsis at the site of injection.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Interventions

Morphine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: June 10, 2025
• Study Start: May 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)