Head-Down Tilt Following Spinal AnesthesiaNCT03491319
Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia - A Randomised Controlled Study
A study testing Group X - head low tilt, Group Y - head low tilt and Group C - neutral in people with Head-Down Tilt Following Spinal Anesthesia, run by Nitte University.
Trial summary
Subarachnoid block has become an established and reliable method of providing anaesthesia for lower abdominal and lower limb surgeries. Several factors determine the spread of local anaesthetic solutions in CSF. Among them, patient position is an important determining factor. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Head-Down Tilt Following Spinal Anesthesia
- What is being tested?
- Group X - head low tilt, Group Y - head low tilt and Group C - neutral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 31 Jan 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients belonging to ASA physical status I and II undergoing lower abdominal and lower limb surgeries under spinal anaesthesia
Who cannot join
- Patient refusal
- contraindicated for spinal anaesthesia
- allergy to local anaesthetic agents used
- obesity (body mass index >29 kg/m2)
- Pregnancy
About this study
Subarachnoid block has become an established and reliable method of providing anaesthesia for lower abdominal and lower limb surgeries. Several factors determine the spread of local anaesthetic solutions in CSF. Among them, patient position is an important determining factor. Anesthesiologists give various degrees of head down tilt which they believe is both safe for the patient and will result in adequate level of block. Often these are arbitrarily done by the operator as most of the operation theatre tables are not equipped with any device to measure the accurate degree of tilt. As there is no agreement on the effect of Trendelenberg position on height of subarachnoid block, the current clinical study will be undertaken to estimate the effect of operation theatre table tilt at the time of lumbar puncture on the height of subarachnoid block.
Read the detailed description
Subarachnoid block has become an established and reliable method of providing anaesthesia for lower abdominal and lower limb surgeries. A definitive advantage that subarachnoid block provides is the profound nerve block that can be produced in a large part of the body by the relatively simple injection of a small amount of local anaesthetic. Twenty-five factors have been invoked as determinants of the spread of local anaesthetic solutions in CSF. Among them, patient position is an important determining factor.
Operation theatre table tilts have been used to influence the spread of hyperbaric solution to ultimately influence the final height of the block. Studies have shown that a 10 degree head down tilt can result in cephalad spread of analgesia when compared to the horizontal group. So, in cases where the spinal block level was not high enough to perform a given surgery, the Trendelenburg position has been used to extend the level of the block. Hence, it is assumed that a higher level of block can be achieved with a smaller volume of the local anaesthetic agent, thus reducing the side effects. But others have noted that there was no statistically significant increase in the level of block even with 15 degree head down tilt.
In spite of this, anesthesiologists give various degrees of head down tilt which they believe is both safe for the patient and will result in adequate level of block. Often these are arbitrarily done by the operator as most of the operation theatre tables are not equipped with any device to measure the accurate degree of tilt.
An application called clinometer that utilizes the gyroscope sensor and determines the plane of the gadget in vertical as well as horizontal directions has been described. This application can be used to measure the exact degree of tilt given after sub arachnoid block.
As there is no agreement on the effect of Trendelenberg position on height of subarachnoid block, the current clinical study will be undertaken to estimate the effect of operation theatre table tilt at the time of lumbar puncture on the height of subarachnoid block.
- Being tested
- Group X - head low tilt, Group Y - head low tilt, Group C - neutral
- Keywords
- Anesthetics, Local, Head-Down Tilt, Anesthesia, Spinal, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group X - head low tiltProcedure or surgery
spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal anaesthesia
Group Y - head low tiltProcedure or surgery
the table was put in 10 degree head low position before proceeding to give spinal anaesthesia. Head low position was maintained for 10 minutes following spinal
Group C - neutralProcedure or surgery
spinal anaesthesia was given with table in neutral positon. Patient was maintained in supine position for 10 minutes following spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group C Control | Placebo comparator | spinal anaesthesia was given with table in neutral positon. Same position was maintained after spinal anaesthesia Receives: Procedure: Group C - neutral |
| Group X | Active comparator | spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal Receives: Procedure: Group X - head low tilt |
| Group Y | Active comparator | the table was put in 10 degree head low position before proceeding to give spinal anaesthesia. Head low position was maintained for 10 minutes following spinal Receives: Procedure: Group Y - head low tilt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum height of block
Measured: from 5 minutes to 150 minutes after intrathecal injection
Two segment regression time
time from injection of spinal drug to regression of the sensory block by two segments from the maximum
Measured: from 5 minutes to 150 minutes after intrathecal injection
Secondary outcomes (3)
Hypotension
drop in systolic blood pressure to less than 30% of baseline values or systolic blood pressure (SBP) below 90mmHg
Measured: every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection
Tachycardia
heart rate more than 100bpm or increase by more than 30% over baseline value.
Measured: every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection.
Bradycardia
heart rate less than 50bpm or decrease by more than 30% below baseline value.
Measured: every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Oct 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Head-Down Tilt Following Spinal 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly allocated to one of the 3 groups by closed envelope method
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitte University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sara Jaison, Nitte University
- Investigators
- Sripada Mehandale, MBBS, MD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491319
- Sponsor's protocol ID
- nitteU
- Status last verified
- Jul 2017
- First submitted
- 31 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
PubMed 11118174Sinclair CJ, Scott DB, Edstrom HH. Effect of the trendelenberg position on spinal anaesthesia with hyperbaric bupivacaine. Br J Anaesth. 1982 May;54(5):497-500. doi: 10.1093/bja/54.5.497.
PubMed 7073918Dixit RB, Neema MM. Use of an Android application "clinometer" for measurement of head down tilt given during subarachnoid block. Saudi J Anaesth. 2016 Jan-Mar;10(1):29-32. doi: 10.4103/1658-354X.169471.
PubMed 26955307Kim JT, Shim JK, Kim SH, Jung CW, Bahk JH. Trendelenburg position with hip flexion as a rescue strategy to increase spinal anaesthetic level after spinal block. Br J Anaesth. 2007 Mar;98(3):396-400. doi: 10.1093/bja/ael370. Epub 2007 Feb 5.
PubMed 17283005Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available.
PubMed 15220175Miyabe M, Namiki A. The effect of head-down tilt on arterial blood pressure after spinal anesthesia. Anesth Analg. 1993 Mar;76(3):549-52. doi: 10.1213/00000539-199303000-00017.
PubMed 8452265
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia - A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03491319
- Acronym / sponsor ID
- nitteU
- Keywords
- Anesthetics, Local, Head-Down Tilt, Anesthesia, Spinal, hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nitte UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 9 Apr 2018 (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.
Subarachnoid block has become an established and reliable method of providing anaesthesia for lower abdominal and lower limb surgeries. Several factors determine the spread of local anaesthetic solutions in CSF. Among them, patient position is an important determining factor. Anesthesiologists give various degrees of head down tilt which they believe is both safe for the patient and will result in adequate level of block. Often these are arbitrarily done by the operator as most of the operation theatre tables are not equipped with any device to measure the accurate degree of tilt. As there is no agreement on the effect of Trendelenberg position on height of subarachnoid block, the current clinical study will be undertaken to estimate the effect of operation theatre table tilt at the time of lumbar puncture on the height of subarachnoid block.
Detailed description
Subarachnoid block has become an established and reliable method of providing anaesthesia for lower abdominal and lower limb surgeries. A definitive advantage that subarachnoid block provides is the profound nerve block that can be produced in a large part of the body by the relatively simple injection of a small amount of local anaesthetic. Twenty-five factors have been invoked as determinants of the spread of local anaesthetic solutions in CSF. Among them, patient position is an important determining factor.
Operation theatre table tilts have been used to influence the spread of hyperbaric solution to ultimately influence the final height of the block. Studies have shown that a 10 degree head down tilt can result in cephalad spread of analgesia when compared to the horizontal group. So, in cases where the spinal block level was not high enough to perform a given surgery, the Trendelenburg position has been used to extend the level of the block. Hence, it is assumed that a higher level of block can be achieved with a smaller volume of the local anaesthetic agent, thus reducing the side effects. But others have noted that there was no statistically significant increase in the level of block even with 15 degree head down tilt.
In spite of this, anesthesiologists give various degrees of head down tilt which they believe is both safe for the patient and will result in adequate level of block. Often these are arbitrarily done by the operator as most of the operation theatre tables are not equipped with any device to measure the accurate degree of tilt.
An application called clinometer that utilizes the gyroscope sensor and determines the plane of the gadget in vertical as well as horizontal directions has been described. This application can be used to measure the exact degree of tilt given after sub arachnoid block.
As there is no agreement on the effect of Trendelenberg position on height of subarachnoid block, the current clinical study will be undertaken to estimate the effect of operation theatre table tilt at the time of lumbar puncture on the height of subarachnoid block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients were randomly allocated to one of the 3 groups by closed envelope method
| Arm | Type | Receives |
|---|---|---|
| Group C Control | Placebo comparator | Procedure: Group C - neutralspinal anaesthesia was given with table in neutral positon. Same position was maintained after spinal anaesthesia |
| Group X | Active comparator | Procedure: Group X - head low tiltspinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal |
| Group Y | Active comparator | Procedure: Group Y - head low tiltthe table was put in 10 degree head low position before proceeding to give spinal anaesthesia. Head low position was maintained for 10 minutes following spinal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients belonging to ASA physical status I and II undergoing lower abdominal and lower limb surgeries under spinal anaesthesia
Key exclusion criteria (5 listed)
- Patient refusal
- contraindicated for spinal anaesthesia
- allergy to local anaesthetic agents used
- obesity (body mass index >29 kg/m2)
- Pregnancy
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 |
|---|---|---|
| Group X - head low tiltspinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal anaesthesia | Procedure or surgery | Group X |
| Group Y - head low tiltthe table was put in 10 degree head low position before proceeding to give spinal anaesthesia. Head low position was maintained for 10 minutes following spinal | Procedure or surgery | Group Y |
| Group C - neutralspinal anaesthesia was given with table in neutral positon. Patient was maintained in supine position for 10 minutes following spinal anaesthesia | Procedure or surgery | Group C Control |
Primary outcome
Maximum height of block
Time frame: from 5 minutes to 150 minutes after intrathecal injection
Two segment regression time
Time frame: from 5 minutes to 150 minutes after intrathecal injection
time from injection of spinal drug to regression of the sensory block by two segments from the maximum
3 secondary outcomes
Hypotension
Time frame: every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection
Tachycardia
Time frame: every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection.
Bradycardia
Time frame: every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection
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 9 Apr 2018.
- Background: PubMed 11118174Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
- Background: PubMed 7073918Sinclair CJ, Scott DB, Edstrom HH. Effect of the trendelenberg position on spinal anaesthesia with hyperbaric bupivacaine. Br J Anaesth. 1982 May;54(5):497-500. doi: 10.1093/bja/54.5.497.
- Background: PubMed 26955307Dixit RB, Neema MM. Use of an Android application "clinometer" for measurement of head down tilt given during subarachnoid block. Saudi J Anaesth. 2016 Jan-Mar;10(1):29-32. doi: 10.4103/1658-354X.169471.
- Background: PubMed 17283005Kim JT, Shim JK, Kim SH, Jung CW, Bahk JH. Trendelenburg position with hip flexion as a rescue strategy to increase spinal anaesthetic level after spinal block. Br J Anaesth. 2007 Mar;98(3):396-400. doi: 10.1093/bja/ael370. Epub 2007 Feb 5.
- Results publication: PubMed 15220175Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available.
- Results publication: PubMed 8452265Miyabe M, Namiki A. The effect of head-down tilt on arterial blood pressure after spinal anesthesia. Anesth Analg. 1993 Mar;76(3):549-52. doi: 10.1213/00000539-199303000-00017.
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.
Sripada Mehandale, MBBS, MD study director
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Group X - head low tilt, Group Y - head low tilt and Group C - neutral in people with Head-Down Tilt Following Spinal Anesthesia, run by Nitte University.
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 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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum height of block (time frame: from 5 minutes to 150 minutes after intrathecal injection). 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 NCT03491319, which also lists 6 linked publications.
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 9 Apr 2018.