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Completed

NCT Number: NCT07012590

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine

Drug

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

Dexmedetomidine

Drug

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

Erector spinae plane block

Other

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

Primary outcomes

  1. Degree of pain

    Time frame: 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 outcomes

  1. Duration of sensory block

    Time frame: Intraoperatively

    Duration of sensory block was assessed.

  2. Time to first rescue analgesia

    Time frame: 48 hours postoperatively

    Time to first rescue analgesia was assessed from the end of surgery till first dose of pethidine administrated.

  3. Total opioid consumption

    Time frame: 48 hours postoperatively

    If the Visual analogue scale (VAS) is ≥ 3, intravenous pethidine was given (0.5mg/kg).

  4. Heart rate

    Time frame: 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.

  5. Mean arterial pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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