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

Not Applicable

Completed

• Conditions: Adjuvants; Bupivacaine; Ultrasound; Erector Spinae Plane Block; Open Subcostal Renal Surgeries; Morphine; Dexmedetomidine
• Interventions: Drug: Morphine; Drug: Dexmedetomidine; Other: Erector spinae plane block

• Registration Number: NCT07012590
• Lead Sponsor: Kafrelsheikh University

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.

Detailed Description

The postoperative pain that occurs because of the wide flank incision ranges from a moderate to severe intensity and, in some patients, can become chronic.

The erector spinae plane block (ESPB) is a novel interfascial plane technique, aiming to block the dorsal and ventral rami of the spinal nerves to provide visceral and somatic multi-dermatomal analgesia of the cervical, thoracic, and lumbar levels.

Adjuvants to local anesthetics, such as morphine and dexmedetomidine, can be used to improve the quality and duration of peripheral nerve block effects.

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-31
• Study First Submitted QC: 2025-05-31
• Last Update Submitted: 2025-05-31
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine group	Morphine	Patients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%.
Dexmedetomidine group	Dexmedetomidine	Patients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%.
Control group	Erector spinae plane block	Patients received erector spinae plane block with bupivacaine 30 ml 0.25% only.

Primary Outcome Measures

Name	Time	Method
Degree of pain	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	48 hours postoperatively	Mean arterial pressure was recorded at baseline, after injection then every 30 min till the end of surgery and after surgery at 0, 2, 4, 6, 8, 12, 24 and 48 h.
Time to first rescue analgesia	48 hours postoperatively	Time to first rescue analgesia was assessed from the end of surgery till first dose of pethidine administrated.
Total opioid consumption	48 hours postoperatively	If the Visual analogue scale (VAS) is ≥ 3, intravenous pethidine was given (0.5mg/kg).
Heart rate	48 hours postoperatively	Heart rate was recorded at baseline, after injection then every 30 min till the end of surgery and after surgery at 0, 2, 4, 6, 8, 12, 24 and 48 h.
Duration of sensory block	Intraoperatively	Duration of sensory block was assessed.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt