Subtenon AnesthesiaPhase 3NCT02282774
Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery
A Phase 3 study testing 2% lidocaine and 0.5% bupivacaine in people with Subtenon Anesthesia, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for vitreoretinal surgery. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Subtenon Anesthesia
- What is being tested?
- 2% lidocaine and 0.5% bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2013to Jun 2014
- Phase
- Phase 3
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective retinal surgery under general anesthesia
Who cannot join
- ASA physical status > Grade II,
- psychiatric conditions,
- neurological impairment,
- deafness with whom communication would be difficult in the postoperative period,
- clotting abnormalities,
- contraindications for regional anesthesia,
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- drug abuse,
- history of allergy to the study drugs,
- previous vitreoretinal or strabismus surgery,
- endophthalmitis, or inflammatory eye pathology
- taking analgesics, antiemetics or drugs that might affect hemodynamics
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University Hospital at King Saud University
Riyadh, Riyadh Region, 11411
About this study
To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for vitreoretinal surgery.
- Conditions
- Subtenon Anesthesia
- Being tested
- 2% lidocaine and 0.5% bupivacaine, Sham subtenon block
- Keywords
- Vitreoretinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% lidocaine and 0.5% bupivacaineDrug
Under general anesthesia and the operating microscope, a Lieberman lid speculum was placed and the conjunctiva was cleaned with 4% povidone iodine solution. The surgeon then created a fornix-based incision through conjunctiva and tenon's tissue inferonasally midway between the insertions of the medial and inferior rectus muscles, with blunt Wescott scissors to expose the scleral surface before tunneling posteriorly with curved Stevens scissors to create a small channel to the posterior subtenon space. A blunt-tipped subtenon cannula was then inserted into the posterior subtenon space, 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture versus saline was introduced and the drug solution was injected slowly into the subtenon space. After administration of local anesthetic mixture, the eyelid was gently taped down, and no ocular massage was performed
Sham subtenon blockDrug
| Study group | Role | What they receive |
|---|---|---|
| SB | Experimental | receive subtenon block of 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture Receives: Drug: 2% lidocaine and 0.5% bupivacaine |
| C | Sham comparator | receive subtenon block of 4mL saline Receives: Drug: Sham subtenon block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to first postoperative analgesic dose
Pain was evaluated using a VNS chart (0-no pain at all, 10-the worst pain imaginable) at 30 min, 1, 2, 4, 6, 12,18 and 24 hours postoperatively. During PACU stay, if the patient complain of pain postoperatively (VNS ≥ 4), morphine boluses of 25 µg /kg (injected at 10-min intervals) was administered intravenously if requested until the pain subsided for a maximum dose of 10 mg. At the end of 2 h, the patients were transferred from the PACU to the ward where the pain was assessed, paracetamol 15 mg/kg was given intravenously and was repeated every 4 hours if needed in the ward by a nurse who is blinded to the study group as paracetamol is the standard post-operative pain medication for patients undergoing ophthalmic surgery at our institute. Time to first post-operative analgesic, which is the time, elapsed between end of the surgical procedure and first administration of an analgesic was noted
Measured: 24 hrs
Secondary outcomes (5)
postoperative pain scores
Pain was evaluated using a VNS chart (0-no pain at all, 10-the worst pain imaginable) at 30 min, 1, 2, 4, 6, 12,18 and 24 hours postoperatively. During PACU stay, if the patient complain of pain postoperatively (VNS ≥ 4), morphine boluses of 25 µg /kg (injected at 10-min intervals) was administered intravenously if requested until the pain subsided for a maximum dose of 10 mg. At the end of 2 h, the patients were transferred from the PACU to the ward where the pain was assessed, paracetamol 15 mg/kg was given intravenously and was repeated every 4 hours if needed in the ward by a nurse who is blinded to the study group as paracetamol is the standard post-operative pain medication for patients undergoing ophthalmic surgery at our institute. Time to first post-operative analgesic, which is the time, elapsed between end of the surgical procedure and first administration of an analgesic was noted.
Measured: First 24 hrs after surgery
number of patients requiring rescue analgesics during the 24-h study period
Measured: during the whole study (6 months)
consumption of rescue analgesics
The total number of patients receiving rescue analgesia is recorded
Measured: during the whole study (6 months)
incidence of oculocardiac reflex
Measured: during time of surgery
incidence of postoperative nausea/vomiting
The incidence of postoperative nausea and vomiting (PONV) was assessed by a nurse (who was blinded to the study drug) for the first 2 h in the PACU and subsequently in the ward at 6, 12 and 24 h and Only 2 possible answers was accepted (yes) or (no). Nausea was defined as subjective sensation of discomfort associated with the awareness of the urge to vomit. Vomiting was defined as a forceful expulsion of gastric contents through the mouth. Rescue antiemetic (Ondansetron 0.15 mg/kg) was given if the patient had persistent nausea or more than a single episode of vomiting or whenever patients request medication and number of patients required rescue anti-emetic postoperatively were recorded
Measured: First 24 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtenon AnesthesiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Abouammoh, King Saud University
- Investigators
- Marwan Abouammoh, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282774
- Sponsor's protocol ID
- E-13-968
- Status last verified
- Oct 2014
- First submitted
- 31 Oct 2014
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery
- ClinicalTrials.gov ID
- NCT02282774
- Acronym / sponsor ID
- E-13-968
- Conditions
- Subtenon Anesthesia
- Keywords
- Vitreoretinal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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.
To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for vitreoretinal surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB | Experimental | Drug: 2% lidocaine and 0.5% bupivacainereceive subtenon block of 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture |
| C | Sham comparator | Drug: Sham subtenon blockreceive subtenon block of 4mL saline |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing elective retinal surgery under general anesthesia
Key exclusion criteria (11 listed)
- ASA physical status > Grade II,
- psychiatric conditions,
- neurological impairment,
- deafness with whom communication would be difficult in the postoperative period,
- clotting abnormalities,
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 |
|---|---|---|
| 2% lidocaine and 0.5% bupivacaineUnder general anesthesia and the operating microscope, a Lieberman lid speculum was placed and the conjunctiva was cleaned with 4% povidone iodine solution. The surgeon then created a fornix-based incision through conjunctiva and tenon's tissue inferonasally midway between the insertions of the medial and inferior rectus muscles, with blunt Wescott scissors to expose the scleral surface before tunneling posteriorly with curved Stevens scissors to create a small channel to the posterior subtenon space. A blunt-tipped subtenon cannula was then inserted into the posterior subtenon space, 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture versus saline was introduced and the drug solution was injected slowly into the subtenon space. After administration of local anesthetic mixture, the eyelid was gently taped down, and no ocular massage was performed | Drug | SB |
| Sham subtenon block | Drug | C |
Primary outcome
the time to first postoperative analgesic dose
Time frame: 24 hrs
Pain was evaluated using a VNS chart (0-no pain at all, 10-the worst pain imaginable) at 30 min, 1, 2, 4, 6, 12,18 and 24 hours postoperatively. During PACU stay, if the patient complain of pain postoperatively (VNS ≥ 4), morphine boluses of 25 µg /kg (injected at 10-min intervals) was administered intravenously if requested until the pain subsided for a maximum dose of 10 mg. At the end of 2 h, the patients were transferred from the PACU to the ward where the pain was assessed, paracetamol 15 mg/kg was given intravenously and was repeated every 4 hours if needed in the ward by a nurse who is blinded to the study group as paracetamol is the standard post-operative pain medication for patients undergoing ophthalmic surgery at our institute. Time to first post-operative analgesic, which is the time, elapsed between end of the surgical procedure and first administration of an analgesic was noted
5 secondary outcomes
postoperative pain scores
Time frame: First 24 hrs after surgery
number of patients requiring rescue analgesics during the 24-h study period
Time frame: during the whole study (6 months)
consumption of rescue analgesics
Time frame: during the whole study (6 months)
incidence of oculocardiac reflex
Time frame: during time of surgery
incidence of postoperative nausea/vomiting
Time frame: First 24 hrs after surgery
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 4 Nov 2014.
Related trials for Subtenon Anesthesia
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.
Marwan Abouammoh, MD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% lidocaine and 0.5% bupivacaine in people with Subtenon Anesthesia, run by King Saud University at 1 site in Saudi Arabia.
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 11 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 4 Nov 2014. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the time to first postoperative analgesic dose (time frame: 24 hrs). 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 4 Nov 2014.