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

NCT ID: NCT07012590

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-07-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Morphine group

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

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

Dexmedetomidine group

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Control group

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

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type OTHER

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

Interventions

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Morphine

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Erector spinae plane block

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Essam Kaka

Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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KFSIRB200-525

Identifier Type: -

Identifier Source: org_study_id

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