MorphineNCT07012590
Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Open Subcostal Renal Surgeries
A study testing Morphine, Dexmedetomidine and Erector spinae plane block in people with Morphine and Dexmedetomidine, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Morphine, Dexmedetomidine, Adjuvants
- What is being tested?
- Morphine, Dexmedetomidine and Erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's approval.
- Age: 20 - 65 years.
- Physical Status: American Society of Anesthesiologists (ASA) I \& II.
- Patients undergoing open subcostal renal surgeries.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Morphine, Dexmedetomidine, Adjuvants, Bupivacaine, Ultrasound, Erector Spinae Plane Block
- Being tested
- Morphine, Dexmedetomidine, Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Patients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%.
DexmedetomidineDrug
Patients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%.
Erector spinae plane blockOther
Patients received erector spinae plane block with bupivacaine 30 ml 0.25% only.
| Study group | Role | What they receive |
|---|---|---|
| Morphine group | Experimental | Patients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%. Receives: Drug: Morphine |
| Dexmedetomidine group | Experimental | Patients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%. Receives: Drug: Dexmedetomidine |
| Control group | Active comparator | Patients received erector spinae plane block with bupivacaine 30 ml 0.25% only. Receives: Other: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Duration of sensory block
Duration of sensory block was assessed.
Measured: Intraoperatively
Time to first rescue analgesia
Time to first rescue analgesia was assessed from the end of surgery till first dose of pethidine administrated.
Measured: 48 hours postoperatively
Total opioid consumption
If the Visual analogue scale (VAS) is ≥ 3, intravenous pethidine was given (0.5mg/kg).
Measured: 48 hours postoperatively
Heart rate
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.
Measured: 48 hours postoperatively
Mean arterial pressure
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.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 May 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MorphineStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Essam Kaka, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012590
- Sponsor's protocol ID
- KFSIRB200-525
- Status last verified
- May 2025
- First submitted
- 31 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Open Subcostal Renal Surgeries
- ClinicalTrials.gov ID
- NCT07012590
- Acronym / sponsor ID
- KFSIRB200-525
- Conditions
- Morphine, Dexmedetomidine, Adjuvants, Bupivacaine, Ultrasound, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morphine group | Experimental | Drug: MorphinePatients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%. |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%. |
| Control group | Active comparator | Other: Erector spinae plane blockPatients received erector spinae plane block with bupivacaine 30 ml 0.25% only. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient's approval.
- Age: 20 - 65 years.
- Physical Status: American Society of Anesthesiologists (ASA) I \& II.
- Patients undergoing open subcostal renal surgeries.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphinePatients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%. | Drug | Morphine group |
| DexmedetomidinePatients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%. | Drug | Dexmedetomidine group |
| Erector spinae plane blockPatients received erector spinae plane block with bupivacaine 30 ml 0.25% only. | Other | Control group |
Primary outcome
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.
5 secondary outcomes
Duration of sensory block
Time frame: Intraoperatively
Time to first rescue analgesia
Time frame: 48 hours postoperatively
Total opioid consumption
Time frame: 48 hours postoperatively
Heart rate
Time frame: 48 hours postoperatively
Mean arterial pressure
Time frame: 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine, Dexmedetomidine and Erector spinae plane block in people with Morphine and Dexmedetomidine, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.