PainNCT05555147
The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Period of Hypophysectomy
A study testing nerve block with 0.5% ropivacaine and without any nerve block in people with Pain and Nerve Block, run by Tongji Hospital at 1 site in China.
Trial summary
The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain which is difficult to suppress at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Nerve Block
- What is being tested?
- nerve block with 0.5% ropivacaine and without any nerve block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 28 Sep 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Elective endoscopic binostril transnasal transsphenoidal resection
- 2. Patients aged between 18 and 65.
- 3. American Society of Anesthesiologists (ASA) physical status I, Ⅱ and III
Who cannot join
- 1. Emergency operation.
- 2. Patients allergic to ropivacaine.
- 3. Infection nearby the puncture point.
- 4. Patients with preoperative usage of sedative and analgesic drugs with history of alcohol abuse.
- 5. Patient with renal insufficiency or hepatic failure.
- 6. Patients who have undergone craniotomy in the recent 6 months.
- 7. Pregnant or lactating women, being participating in other studies.
- 8. Patients unable to cooperate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Analgesia After Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary: a Prospective, Randomized Study
The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain which is difficult to suppress at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can provide stable hemodynamics and reduce the hemodynamic fluctuation the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear.
Read the detailed description
Surgical stimulation is one of the important factors leading to hemodynamic fluctuation and affecting postoperative recovery quality. The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain because of there were numerous nerve endings at the surgical site which is originated from branches of the trigeminal nerve (including infraorbital and infratrochlear nerve). It's difficult to suppress intraoperative stimulation at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. It's reported that pterygomaxillary fossa block can inhibit hypertension caused by surgical procedures, however the block may cause complications because of its complicated operations. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can reduce the pain in the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear. Therefore, the investigators propose the hypothesis that preoperative bilateral infraorbital and infratrochlear nerve block could effectively reduce the pain in patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary. The objective of this study is to observe the heart rate and blood pressure at a specific point in time during the operation and pain at 2, 8, 24, 48 hours postoperatively between adult patients receiving or not receiving bilateral infraorbital and infratrochlear nerve block.
- Conditions
- Pain, Nerve Block
- Being tested
- nerve block with 0.5% ropivacaine, without any nerve block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve block with 0.5% ropivacaineDrug
After general anesthesia, the patients will receive bilateral infraorbital and infratrochlear nerve block 30 minutes prior to surgery. Infraorbital nerve block is performed while using an extraoral approach. A 25-gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 ml of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed infratrochlear nerve block. After negative aspiration of blood, 1 ml of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner.
without any nerve blockOther
Also called nerve block with 0.5% ropivacaine
Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block Group | Experimental | Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. Infraorbital nerve block was performed while using an extraoral approach. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 mL of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner. Receives: Drug: nerve block with 0.5% ropivacaine |
| Control Group | Sham comparator | Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block. Receives: Other: without any nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial pressure (MAP) before nerve block
mean arterial pressure (MAP) before nerve block
Measured: before nerve block
heat rate (HR) before nerve block
heat rate (HR) before nerve block
Measured: before nerve block
MAP within 10 minutes after nerve block
MAP within 10 minutes after nerve block
Measured: within 10 minutes after nerve block
HR within 10 minutes after nerve block
HR within 10 minutes after nerve block
Measured: within 10 minutes after nerve block
MAP before nasal mucosal dissection
MAP before nasal mucosal dissection
Measured: before nasal mucosal dissection
HR before nasal mucosal dissection
HR before nasal mucosal dissection
Measured: before nasal mucosal dissection
MAP immediately after nasal mucosal dissection
MAP immediately after nasal mucosal dissection
Measured: immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection
Measured: immediately after nasal mucosal dissection
MAP before septum resection
MAP before septum resection
Measured: before septum resection
HR before septum resection
HR before septum resection
Measured: before septum resection
MAP immediately after septum resection
MAP immediately after septum resection
Measured: immediately after septum resection
HR immediately after septum resection
HR immediately after septum resection
Measured: immediately after septum resection
MAP before sella bone resection
MAP before sella bone resection
Measured: before sella bone resection
HR before sella bone resection
HR before sella bone resection
Measured: before sella bone resection
MAP after sella bone resection
MAP after sella bone resection
Measured: before sella bone resection
HR immediately after sella bone resection
HR immediately after sella bone resection
Measured: immediately after sella bone resection
MAP before dural incision of sella
MAP before dural incision of sella
Measured: before dural incision of sella
HR before dural incision of sella
HR before dural incision of sella
Measured: before dural incision of sella
MAP immediately after dural incision of sella
MAP immediately after dural incision of sella
Measured: immediately after dural incision of sella
HR immediately after dural incision of sella
HR immediately after dural incision of sella
Measured: immediately after dural incision of sella
MAP before exploration of pituitary fossa
MAP before exploration of pituitary fossa
Measured: before exploration of pituitary fossa
HR before exploration of pituitary fossa
HR before exploration of pituitary fossa
Measured: before exploration of pituitary fossa
MAP immediately after exploration of pituitary fossa
MAP immediately after exploration of pituitary fossa
Measured: immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
Measured: immediately after exploration of pituitary fossa
Secondary outcomes (9)
numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery)
numerical rating scale (NRS) score when patient enters PACU (immediately after surgery). The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: when patient enters PACU (immediately after surgery)
numerical rating scale (NRS) score before patient leaves PACU
numerical rating scale (NRS) score before patient leaves PACU. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: before patient leaves PACU
NRS 2 hours after surgery
NRS 2 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: 2 hours after surgery
NRS 8 hours after surgery
NRS 8 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: 8 hours after surgery
NRS 24 hours after surgery
NRS 24 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: 24 hours after surgery
NRS 48 hours after surgery
NRS 48 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: 48 hours after surgery
quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery
quality of recovery Scale (QoR-15): QoR-15 1 day after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality.
Measured: 1 day after surgery
quality of recovery Scale: QoR-15 3 days after surgery
quality of recovery Scale: QoR-15 3 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality.
Measured: 3 days after surgery
quality of recovery Scale: QoR-15 7 days after surgery
quality of recovery Scale: QoR-15 7 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Sep 2022
- Primary completion28 Sep 2023 (estimated)
- Study completion28 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. The patient's head was positioned on a central line in the supine position. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger . 2 mL of the study solution was slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the study solution was injected. Contralateral nerve block was performed in the same manner.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555147
- Sponsor's protocol ID
- TJ2012S152
- Status last verified
- Sep 2022
- First submitted
- 1 Mar 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Analgesia After Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT05555147
- Acronym / sponsor ID
- TJ2012S152
- Conditions
- Pain, Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 28 Sep 2023 (estimated)
- First posted
- 26 Sep 2022 (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.
The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain which is difficult to suppress at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can provide stable hemodynamics and reduce the hemodynamic fluctuation the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear.
Detailed description
Surgical stimulation is one of the important factors leading to hemodynamic fluctuation and affecting postoperative recovery quality. The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain because of there were numerous nerve endings at the surgical site which is originated from branches of the trigeminal nerve (including infraorbital and infratrochlear nerve). It's difficult to suppress intraoperative stimulation at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. It's reported that pterygomaxillary fossa block can inhibit hypertension caused by surgical procedures, however the block may cause complications because of its complicated operations. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can reduce the pain in the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear. Therefore, the investigators propose the hypothesis that preoperative bilateral infraorbital and infratrochlear nerve block could effectively reduce the pain in patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary. The objective of this study is to observe the heart rate and blood pressure at a specific point in time during the operation and pain at 2, 8, 24, 48 hours postoperatively between adult patients receiving or not receiving bilateral infraorbital and infratrochlear nerve block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. The patient's head was positioned on a central line in the supine position. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger . 2 mL of the study solution was slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the study solution was injected. Contralateral nerve block was performed in the same manner.
| Arm | Type | Receives |
|---|---|---|
| Nerve Block Group | Experimental | Drug: nerve block with 0.5% ropivacaineThirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. Infraorbital nerve block was performed while using an extraoral approach. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 mL of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner. |
| Control Group | Sham comparator | Other: without any nerve blockPatients receiving general anesthesia without Infraorbital and Infratrochlear nerve block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Elective endoscopic binostril transnasal transsphenoidal resection
- 2. Patients aged between 18 and 65.
- 3. American Society of Anesthesiologists (ASA) physical status I, Ⅱ and III
Key exclusion criteria (8 listed)
- 1. Emergency operation.
- 2. Patients allergic to ropivacaine.
- 3. Infection nearby the puncture point.
- 4. Patients with preoperative usage of sedative and analgesic drugs with history of alcohol abuse.
- 5. Patient with renal insufficiency or hepatic failure.
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 0.5% ropivacaineAfter general anesthesia, the patients will receive bilateral infraorbital and infratrochlear nerve block 30 minutes prior to surgery. Infraorbital nerve block is performed while using an extraoral approach. A 25-gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 ml of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed infratrochlear nerve block. After negative aspiration of blood, 1 ml of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner. | Drug | Nerve Block Group |
| without any nerve blockAlso: nerve block with 0.5% ropivacainePatients receiving general anesthesia without Infraorbital and Infratrochlear nerve block. | Other | Control Group |
Primary outcome
mean arterial pressure (MAP) before nerve block
Time frame: before nerve block
mean arterial pressure (MAP) before nerve block
heat rate (HR) before nerve block
Time frame: before nerve block
heat rate (HR) before nerve block
MAP within 10 minutes after nerve block
Time frame: within 10 minutes after nerve block
MAP within 10 minutes after nerve block
HR within 10 minutes after nerve block
Time frame: within 10 minutes after nerve block
HR within 10 minutes after nerve block
MAP before nasal mucosal dissection
Time frame: before nasal mucosal dissection
MAP before nasal mucosal dissection
HR before nasal mucosal dissection
Time frame: before nasal mucosal dissection
HR before nasal mucosal dissection
MAP immediately after nasal mucosal dissection
Time frame: immediately after nasal mucosal dissection
MAP immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection
Time frame: immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection
MAP before septum resection
Time frame: before septum resection
MAP before septum resection
HR before septum resection
Time frame: before septum resection
HR before septum resection
MAP immediately after septum resection
Time frame: immediately after septum resection
MAP immediately after septum resection
HR immediately after septum resection
Time frame: immediately after septum resection
HR immediately after septum resection
MAP before sella bone resection
Time frame: before sella bone resection
MAP before sella bone resection
HR before sella bone resection
Time frame: before sella bone resection
HR before sella bone resection
MAP after sella bone resection
Time frame: before sella bone resection
MAP after sella bone resection
HR immediately after sella bone resection
Time frame: immediately after sella bone resection
HR immediately after sella bone resection
MAP before dural incision of sella
Time frame: before dural incision of sella
MAP before dural incision of sella
HR before dural incision of sella
Time frame: before dural incision of sella
HR before dural incision of sella
MAP immediately after dural incision of sella
Time frame: immediately after dural incision of sella
MAP immediately after dural incision of sella
HR immediately after dural incision of sella
Time frame: immediately after dural incision of sella
HR immediately after dural incision of sella
MAP before exploration of pituitary fossa
Time frame: before exploration of pituitary fossa
MAP before exploration of pituitary fossa
HR before exploration of pituitary fossa
Time frame: before exploration of pituitary fossa
HR before exploration of pituitary fossa
MAP immediately after exploration of pituitary fossa
Time frame: immediately after exploration of pituitary fossa
MAP immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
Time frame: immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
9 secondary outcomes
numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery)
Time frame: when patient enters PACU (immediately after surgery)
numerical rating scale (NRS) score before patient leaves PACU
Time frame: before patient leaves PACU
NRS 2 hours after surgery
Time frame: 2 hours after surgery
NRS 8 hours after surgery
Time frame: 8 hours after surgery
NRS 24 hours after surgery
Time frame: 24 hours after surgery
NRS 48 hours after surgery
Time frame: 48 hours after surgery
quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery
Time frame: 1 day after surgery
quality of recovery Scale: QoR-15 3 days after surgery
Time frame: 3 days after surgery
quality of recovery Scale: QoR-15 7 days after surgery
Time frame: 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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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 nerve block with 0.5% ropivacaine and without any nerve block in people with Pain and Nerve Block, run by Tongji Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Sep 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
mean arterial pressure (MAP) before nerve block (time frame: before nerve block). The study lists 24 primary outcomes in all. 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 26 Sep 2022.