Post-operative Surgical PainSIONNCT04670614
Regional Anesthesia (Supra-Orbital and Infra-Orbital Nerve Block) (SION) for Pain Management in Trans-sphenoidal Hypophysectomy
A study testing Nerve Block with ropivicaine 0.5% Injectable Solution in people with Post-operative Surgical Pain, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a prospective, randomized, blinded, sham controlled regional anesthetic (supra-orbital and infra-orbital nerve block) pain study to compare the systemic postoperative pain medication requirements in patients having Trans-sphenoidal Pituitary surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Surgical Pain
- What is being tested?
- Nerve Block with ropivicaine 0.5% Injectable Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2017to 25 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult age between 18 and 65
- American Society of Anesthesiology (ASA) 1-2
- Elective pituitary tumor surgery, tumor less than or equal to 2 cm diameter within the sella and no cavernous
- sinus invasion
- Single surgeon, Dr. Kunwar
- Male and female patients
Show all 12Show fewer
- English speaking
- Informed consent
- Not on chronic pre-opertaive pain medications (non-narcotics) in the last 1 week prior to surgery
- No opioid pain medications pre-op in the last 1 month before surgery
- No abuse of recreational drugs (cocaine, methamphetamines, THC (tetrahydrocannabinol), opioids/heroin)
- No herbal medications for pain in the 1-month prior to surgery
Who cannot join
- Age less than 18 years
- Non-English speaking
- Allergy to: Ropivicaine
- Chronic pain condition, including idiopathic migraine as defined by the ICHD (International Classification of Headache Disorders) II criteria, requiring the use of pain medications
- Inability to comprehend or adhere to study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Moffitt Long Hospital
San Francisco, California, 94143
About this study
This is a prospective, randomized, blinded, sham controlled regional anesthetic (supra-orbital and infra-orbital nerve block) pain study to compare the systemic postoperative pain medication requirements in patients having Trans-sphenoidal Pituitary surgery. The patients will receive general anesthesia +/- regional anesthesia for trans-sphenoidal pituitary surgery and systemic pain medication during the intra-operative and postoperative (6hrs) period. The amount of systemic pain medication requirements will be compared between those patients receiving regional and general anesthesia versus general anesthesia alone.
Read the detailed description
Combined regional and general anesthesia for surgery is known to provide superior pain control in the peri-operative period (intra and post-operative). Of particular interest in neurosurgery are more rapid patient awakening and earlier ability to perform adequate post-operative neurological exam. In addition to this, regional anesthesia can decrease the total amount of systemic pain medications necessary and thus decrease their associated side effects. Consequently, less systemic pain medications can benefit the patient in many ways.
By modifying the postop pain regime to include intraoperative regional anesthesia, there could be increased patient satisfaction, and significant economic gains to the hospital through a more streamlined, shorter, more pleasant hospital course for the patient. Patients who have this trans-sphenoidal pituitary surgery are usually same day admission patients who, following their surgery, are admitted for up to 24 hours postoperatively. Usually prolonged admissions result from headache and nausea +/- vomiting. Etiology of the headache is likely multifactorial. One theory is that stimulation of the peripheral trigeminal (Cranial Nerve Number V) fibers in the V1 and V2 distribution of the face by the surgical endoscope and surgical trauma may lead to release of inflammatory mediators and post-operative migraine. It has been shown that repetitive injection of local anesthetics in the distribution of supra-orbital nerve V1 and infra-orbital nerve V2 can decrease the incidence of chronic idiopathic migraine headaches not related to surgery. By administering regional anesthesia to the patient intra-operatively during their general anesthetic for the surgery, pain scores may be reduced, PONV (postoperative nausea and vomiting) decreased, and hospital stay shortened.This study will be examining the use of regional anesthesia (infra-orbital and supra-orbital nerve blocks) combined with general anesthesia versus general anesthesia to observe the systemic opioid consumptions of adult transsphenoidal pituitary surgery patients. Secondary endpoints of the study will be: (1) presence of PONV, (2) time in PACU (post anesthesia care unit) and finally, (3) duration of hospital stay until discharge.
- Conditions
- Post-operative Surgical Pain
- Being tested
- Nerve Block with ropivicaine 0.5% Injectable Solution, Nerve Block with Placebo sham control of 0.9% Normal Saline
- Keywords
- trigeminal nerve block, trans-sphenoidal endoscopic pituitary surgery, supra-orbital nerve block, infra-orbital nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Block with ropivicaine 0.5% Injectable SolutionProcedure or surgery
Peripheral nerve blocks using 0.5% ropivicaine
Nerve Block with Placebo sham control of 0.9% Normal SalineProcedure or surgery
Peripheral Nerve Block with placebo 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block Procedure | Other | Supra-orbital and Infra-orbital peripheral nerve blocks with 0.5% ropivicaine Receives: Procedure: Nerve Block with ropivicaine 0.5% Injectable Solution |
| Placebo sham control | Sham comparator | sham control 0.9% Normal Saline Receives: Procedure: Nerve Block with Placebo sham control of 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 hour post-operative Morphine Requirements in milligrams (mg)
Systemic Intravenous (IV) morphine opioid consumption in mg in 2 groups during first 6 hours post-operatively (regional + general versus only general anesthesia)
Measured: 6 hours post-op
Secondary outcomes (4)
Pain exposure postoperative for 6 hours
Pain score out of max 10 (Scale 0-10). "O" (no Pain) and "10" (worst possible pain)
Measured: 6 hours
Nausea and/or vomiting for 6 hours postoperatively
Nausea score out of max 10 (Scale 0-10)."O" (no nausea) and "10" (worst nausea possible). Presence of vomiting is minimum score of 5/10.
Measured: 6 hours
Time to discharge from Post anesthesia care unit (PACU) in minutes
Time patient spends in PACU from entry time until discharge to the floor in minutes
Measured: post-operative period measured in minutes up to 120 minutes
Time to discharge from hospital in minutes
Time measured in minutes from surgery start to discharge from the hospital
Measured: post-operative time up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Jan 2017
- Primary completion25 Dec 2018
- Study completion25 Dec 2018
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 Post-operative Surgical PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Una Srejic, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670614
- Sponsor's protocol ID
- 15-15700
- Acronym
- SION
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srejic U, Litonius E, Gandhi S, Talke P, Maties O, Siegmueller C, Magsaysay A, Hasen D, Kunwar S, Seth R, Gibson L, Bickler P. Bilateral Superficial Trigeminal Nerve Blocks are not More Effective than a Placebo in Abolishing Post-operative Headache Pain in Pituitary Transsphenoidal Neurosurgery: A Prospective, Randomized, Doubleblinded Clinical Trial. Rev Recent Clin Trials. 2023;18(3):228-237. doi: 10.2174/1574887118666230227113217.
PubMed 36843368
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia (Supra-Orbital and Infra-Orbital Nerve Block) (SION) for Pain Management in Trans-sphenoidal Hypophysectomy
- ClinicalTrials.gov ID
- NCT04670614
- Acronym / sponsor ID
- SION / 15-15700
- Conditions
- Post-operative Surgical Pain
- Keywords
- trigeminal nerve block, trans-sphenoidal endoscopic pituitary surgery, supra-orbital nerve block, infra-orbital nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 17 Dec 2020 (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 is a prospective, randomized, blinded, sham controlled regional anesthetic (supra-orbital and infra-orbital nerve block) pain study to compare the systemic postoperative pain medication requirements in patients having Trans-sphenoidal Pituitary surgery. The patients will receive general anesthesia +/- regional anesthesia for trans-sphenoidal pituitary surgery and systemic pain medication during the intra-operative and postoperative (6hrs) period. The amount of systemic pain medication requirements will be compared between those patients receiving regional and general anesthesia versus general anesthesia alone.
Detailed description
Combined regional and general anesthesia for surgery is known to provide superior pain control in the peri-operative period (intra and post-operative). Of particular interest in neurosurgery are more rapid patient awakening and earlier ability to perform adequate post-operative neurological exam. In addition to this, regional anesthesia can decrease the total amount of systemic pain medications necessary and thus decrease their associated side effects. Consequently, less systemic pain medications can benefit the patient in many ways.
By modifying the postop pain regime to include intraoperative regional anesthesia, there could be increased patient satisfaction, and significant economic gains to the hospital through a more streamlined, shorter, more pleasant hospital course for the patient. Patients who have this trans-sphenoidal pituitary surgery are usually same day admission patients who, following their surgery, are admitted for up to 24 hours postoperatively. Usually prolonged admissions result from headache and nausea +/- vomiting. Etiology of the headache is likely multifactorial. One theory is that stimulation of the peripheral trigeminal (Cranial Nerve Number V) fibers in the V1 and V2 distribution of the face by the surgical endoscope and surgical trauma may lead to release of inflammatory mediators and post-operative migraine. It has been shown that repetitive injection of local anesthetics in the distribution of supra-orbital nerve V1 and infra-orbital nerve V2 can decrease the incidence of chronic idiopathic migraine headaches not related to surgery. By administering regional anesthesia to the patient intra-operatively during their general anesthetic for the surgery, pain scores may be reduced, PONV (postoperative nausea and vomiting) decreased, and hospital stay shortened.This study will be examining the use of regional anesthesia (infra-orbital and supra-orbital nerve blocks) combined with general anesthesia versus general anesthesia to observe the systemic opioid consumptions of adult transsphenoidal pituitary surgery patients. Secondary endpoints of the study will be: (1) presence of PONV, (2) time in PACU (post anesthesia care unit) and finally, (3) duration of hospital stay until discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Block Procedure | Other | Procedure: Nerve Block with ropivicaine 0.5% Injectable SolutionSupra-orbital and Infra-orbital peripheral nerve blocks with 0.5% ropivicaine |
| Placebo sham control | Sham comparator | Procedure: Nerve Block with Placebo sham control of 0.9% Normal Salinesham control 0.9% Normal Saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult age between 18 and 65
- American Society of Anesthesiology (ASA) 1-2
- Elective pituitary tumor surgery, tumor less than or equal to 2 cm diameter within the sella and no cavernous
- sinus invasion
- Single surgeon, Dr. Kunwar
Key exclusion criteria (5 listed)
- Age less than 18 years
- Non-English speaking
- Allergy to: Ropivicaine
- Chronic pain condition, including idiopathic migraine as defined by the ICHD (International Classification of Headache Disorders) II criteria, requiring the use of pain medications
- Inability to comprehend or adhere to study protocol
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 ropivicaine 0.5% Injectable SolutionPeripheral nerve blocks using 0.5% ropivicaine | Procedure or surgery | Nerve Block Procedure |
| Nerve Block with Placebo sham control of 0.9% Normal SalinePeripheral Nerve Block with placebo 0.9% normal saline | Procedure or surgery | Placebo sham control |
Primary outcome
6 hour post-operative Morphine Requirements in milligrams (mg)
Time frame: 6 hours post-op
Systemic Intravenous (IV) morphine opioid consumption in mg in 2 groups during first 6 hours post-operatively (regional + general versus only general anesthesia)
4 secondary outcomes
Pain exposure postoperative for 6 hours
Time frame: 6 hours
Nausea and/or vomiting for 6 hours postoperatively
Time frame: 6 hours
Time to discharge from Post anesthesia care unit (PACU) in minutes
Time frame: post-operative period measured in minutes up to 120 minutes
Time to discharge from hospital in minutes
Time frame: post-operative time up to 36 hours
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 17 Dec 2020.
- Derived from this study: PubMed 36843368Srejic U, Litonius E, Gandhi S, Talke P, Maties O, Siegmueller C, Magsaysay A, Hasen D, Kunwar S, Seth R, Gibson L, Bickler P. Bilateral Superficial Trigeminal Nerve Blocks are not More Effective than a Placebo in Abolishing Post-operative Headache Pain in Pituitary Transsphenoidal Neurosurgery: A Prospective, Randomized, Doubleblinded Clinical Trial. Rev Recent Clin Trials. 2023;18(3):228-237. doi: 10.2174/1574887118666230227113217.
- Individual participant dataSharing planned: No
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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.
Una Srejic, MD principal investigator
University of California, San Diego
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 ropivicaine 0.5% Injectable Solution in people with Post-operative Surgical Pain, run by University of California, San Francisco at 1 site in United States.
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 12 inclusion and 5 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 17 Dec 2020. 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 United States. 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?
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?
6 hour post-operative Morphine Requirements in milligrams (mg) (time frame: 6 hours post-op). 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 NCT04670614, 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 17 Dec 2020.