Pain After SurgeryNCT07241364
Effect of the Superficial Cervical Plexus Block in the Hypotensive Anesthesia of Ear Surgery.
A study testing nerve block with bupivacaine 0.25% in people with Pain After Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
We aimed to evaluate the analgesic effect of ultrasound guided Superficial cervical plexux block in tympanomastoid ear surgeries by comparing it with conventional general anaesthesia using systemic analgesic through observation of intra- and postoperative requirements of the total dose of systemic analgesics, visual… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Pain After Surgery
- What is being tested?
- nerve block with bupivacaine 0.25%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1 - Both genders. 2- Age between 20 -40 years. 3- ASA 1 \& 2 physical status. 4- Patients undergoing simple ear surgery as Tympano-mastoidectomy
Who cannot join
- 1- Infection at or near the injection site. 2- Uncontrolled preoperative hypertension. 3- age < 20 or >40 4- chronic opoid abuse patients. 5- patients with pre existing neuropathy or other neurological diseases. 6- patients on anticoagulation. 7- plt count < 100 or INR > 1.7 8- lengthy surgery more than 3 hours . 9- hypersensitivity to local anesthetics. 10- patients with psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
We aimed to evaluate the analgesic effect of ultrasound guided Superficial cervical plexux block in tympanomastoid ear surgeries by comparing it with conventional general anaesthesia using systemic analgesic through observation of intra- and postoperative requirements of the total dose of systemic analgesics, visual analog scale (VAS) score, total duration of analgesia, vital parameters and the occurrence of any perioperative complications.
Read the detailed description
Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, General anaesthesia (GA) will be induced with intravenous inj. of propofol 2-2.5 mg/kg, , fentanyl 1 microgram/kilogram (μg/kg). and atracuruim 0.5 mg/kg was given for muscle relaxation .
In study Group patients, superficial CPB will be administered in a supine position with the head turned opposite to the side of the block using ultrasound guidance .
Local anaesthetic will be injected alongside the posterior border of the muscle 2-3 cm in cranial and caudal directions. Using a 'fan' technique, the local anaesthetic will be administered subcutaneously and behind the sternocleidomastoid muscle. Ten millilitres of 0.25% bupivacaine were injected for each side of the block using a 1.5-inch 24-gauge needle. [2].
General anaesthesia will maintained with O2 + air (50:50), 3-litre flow, sevoflurane 2% to 2.5% and an intravenous inj. of atracuiruim 0.01 mg/kg every 20 min. An intraoperative rise in heart rate (>100/min) and systolic blood pressure (≥ 20% from pre-induction value) will be recorded and managed by giving intravenous inj. of fentanyl 0.5 microgram/kg in incremental doses (dose of fentanyl did not exceed 3 μg/kg for less than three hours of surgery). At the end of the surgery, the reversal of residual neuromuscular block will be done and the patient will be extubated. The patient will be then transferred to the recovery room and the severity of pain will be assessed by a VAS scale ( visual analog score scale ), which is a straight line denoting one end with no pain and the other end with the worst pain. VAS score was calculated as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-9, severe pain; 10, worst pain. The VAS score will be assessed when the patient could follow verbal commands.
Evaluation of block for adequate analgesia intraoperatively will be done in terms of the total requirement of intravenous analgesics through the observation of heart rate and blood pressure and postoperatively, it will be done by observing VAS score, time of first demand for a bolus of rescue analgesic (intravenous paracetamol) and total requirement of rescue analgesic in 24 hours.. Pulse, mean blood pressure (BP), oxygen saturation (SpO2) and any side effects were also noted.
- Conditions
- Pain After Surgery
- Being tested
- nerve block with bupivacaine 0.25%
- Keywords
- cervical plexus block, hypotensive anesthesia, ear surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve block with bupivacaine 0.25%Procedure or surgery
superficial cervical plexus block (superficial CPB ) will be administered in a supine position with the head turned opposite to the side of the block using ultrasound guidance .
Local anaesthetic will be injected alongside the posterior border of the muscle 2-3 cm in cranial and caudal directions. Using a 'fan' technique, the local anaesthetic will be administered subcutaneously and behind the sternocleidomastoid muscle. Ten millilitres of 0.25% bupivacaine were injected for each side of the block using a 1.5-inch 24-gauge needle..
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | will receive only conventional general anasthesia in ear surgery |
| study group | Experimental | patients will receive superficial cervical plexus block in addittion to general anesthesia Receives: Procedure: nerve block with bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
monitoring pain score using visual analog score (VAS) postoperative . to evaluate the analgesic effect
Measured: 24 hours
analgesia
The number of analgesic doses required for each patient as rescue analgesia (when VAS > 3), will be recorded and statistically compared between the two groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Apr 2025
- Primary completion20 Nov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain After SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia edward aziz zakhary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241364
- Sponsor's protocol ID
- cervical plexus block
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ho B, De Paoli M. Use of Ultrasound-Guided Superficial Cervical Plexus Block for Pain Management in the Emergency Department. J Emerg Med. 2018 Jul;55(1):87-95. doi: 10.1016/j.jemermed.2018.04.030. Epub 2018 May 29.
PubMed 29858144
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Superficial Cervical Plexus Block in the Hypotensive Anesthesia of Ear Surgery.
- ClinicalTrials.gov ID
- NCT07241364
- Acronym / sponsor ID
- cervical plexus block
- Conditions
- Pain After Surgery
- Keywords
- cervical plexus block, hypotensive anesthesia, ear surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Nov 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.
We aimed to evaluate the analgesic effect of ultrasound guided Superficial cervical plexux block in tympanomastoid ear surgeries by comparing it with conventional general anaesthesia using systemic analgesic through observation of intra- and postoperative requirements of the total dose of systemic analgesics, visual analog scale (VAS) score, total duration of analgesia, vital parameters and the occurrence of any perioperative complications.
Detailed description
Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, General anaesthesia (GA) will be induced with intravenous inj. of propofol 2-2.5 mg/kg, , fentanyl 1 microgram/kilogram (μg/kg). and atracuruim 0.5 mg/kg was given for muscle relaxation .
In study Group patients, superficial CPB will be administered in a supine position with the head turned opposite to the side of the block using ultrasound guidance .
Local anaesthetic will be injected alongside the posterior border of the muscle 2-3 cm in cranial and caudal directions. Using a 'fan' technique, the local anaesthetic will be administered subcutaneously and behind the sternocleidomastoid muscle. Ten millilitres of 0.25% bupivacaine were injected for each side of the block using a 1.5-inch 24-gauge needle. [2].
General anaesthesia will maintained with O2 + air (50:50), 3-litre flow, sevoflurane 2% to 2.5% and an intravenous inj. of atracuiruim 0.01 mg/kg every 20 min. An intraoperative rise in heart rate (>100/min) and systolic blood pressure (≥ 20% from pre-induction value) will be recorded and managed by giving intravenous inj. of fentanyl 0.5 microgram/kg in incremental doses (dose of fentanyl did not exceed 3 μg/kg for less than three hours of surgery). At the end of the surgery, the reversal of residual neuromuscular block will be done and the patient will be extubated. The patient will be then transferred to the recovery room and the severity of pain will be assessed by a VAS scale ( visual analog score scale ), which is a straight line denoting one end with no pain and the other end with the worst pain. VAS score was calculated as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-9, severe pain; 10, worst pain. The VAS score will be assessed when the patient could follow verbal commands.
Evaluation of block for adequate analgesia intraoperatively will be done in terms of the total requirement of intravenous analgesics through the observation of heart rate and blood pressure and postoperatively, it will be done by observing VAS score, time of first demand for a bolus of rescue analgesic (intravenous paracetamol) and total requirement of rescue analgesic in 24 hours.. Pulse, mean blood pressure (BP), oxygen saturation (SpO2) and any side effects were also noted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –will receive only conventional general anasthesia in ear surgery |
| study group | Experimental | Procedure: nerve block with bupivacaine 0.25%patients will receive superficial cervical plexus block in addittion to general anesthesia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1 - Both genders. 2- Age between 20 -40 years. 3- ASA 1 \& 2 physical status. 4- Patients undergoing simple ear surgery as Tympano-mastoidectomy
Key exclusion criteria (1 listed)
- 1- Infection at or near the injection site. 2- Uncontrolled preoperative hypertension. 3- age < 20 or >40 4- chronic opoid abuse patients. 5- patients with pre existing neuropathy or other neurological diseases. 6- patients on anticoagulation. 7- plt count < 100 or INR > 1.7 8- lengthy surgery more than 3 hours . 9- hypersensitivity to local anesthetics. 10- patients with psychiatric illness.
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 |
|---|---|---|
| nerve block with bupivacaine 0.25%superficial cervical plexus block (superficial CPB ) will be administered in a supine position with the head turned opposite to the side of the block using ultrasound guidance . Local anaesthetic will be injected alongside the posterior border of the muscle 2-3 cm in cranial and caudal directions. Using a 'fan' technique, the local anaesthetic will be administered subcutaneously and behind the sternocleidomastoid muscle. Ten millilitres of 0.25% bupivacaine were injected for each side of the block using a 1.5-inch 24-gauge needle.. | Procedure or surgery | study group |
Primary outcome
pain
Time frame: 24 hours
monitoring pain score using visual analog score (VAS) postoperative . to evaluate the analgesic effect
analgesia
Time frame: 24 hours
The number of analgesic doses required for each patient as rescue analgesia (when VAS > 3), will be recorded and statistically compared between the two groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 29858144Ho B, De Paoli M. Use of Ultrasound-Guided Superficial Cervical Plexus Block for Pain Management in the Emergency Department. J Emerg Med. 2018 Jul;55(1):87-95. doi: 10.1016/j.jemermed.2018.04.030. Epub 2018 May 29.
- Individual participant dataSharing planned: Undecided
Related trials for Pain After Surgery
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
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 nerve block with bupivacaine 0.25% in people with Pain After Surgery, run by Ain Shams 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
pain (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07241364, which also lists 1 linked publication.
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 21 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.