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Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia - A Randomised Controlled Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491319
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Sara Jaison, Nitte University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Head-Down Tilt Following Spinal Anesthesia Procedure: Group X - head low tilt Procedure: Group Y - head low tilt Procedure: Group C - neutral Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients were randomly allocated to one of the 3 groups by closed envelope method
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: First anaesthesiologist performed the spinal anaesthesia, gave table tilt using clinometer according to group allocation and assessed spinal blockade till 10 min after intrathecal injection. Thereafter it was done by the second anaesthesiologist who was blinded to the patient grouping
Primary Purpose: Supportive Care
Official Title: Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia - A Randomised Controlled Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Arm Intervention/treatment
Placebo Comparator: Group C Control
spinal anaesthesia was given with table in neutral positon. Same position was maintained after spinal anaesthesia
Procedure: Group C - neutral
spinal anaesthesia was given with table in neutral positon. Patient was maintained in supine position for 10 minutes following spinal anaesthesia

Active Comparator: Group X
spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal
Procedure: Group X - head low tilt
spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal anaesthesia

Active Comparator: Group Y
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
Procedure: Group Y - head low tilt
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




Primary Outcome Measures :
  1. Maximum height of block [ Time Frame: from 5 minutes to 150 minutes after intrathecal injection ]
  2. 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


Secondary Outcome Measures :
  1. 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 ]
    drop in systolic blood pressure to less than 30% of baseline values or systolic blood pressure (SBP) below 90mmHg

  2. 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. ]
    heart rate more than 100bpm or increase by more than 30% over baseline value.

  3. 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 ]
    heart rate less than 50bpm or decrease by more than 30% below baseline value.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients belonging to ASA physical status I and II undergoing lower abdominal and lower limb surgeries under spinal anaesthesia

Exclusion Criteria:

  • Patient refusal
  • contraindicated for spinal anaesthesia
  • allergy to local anaesthetic agents used
  • obesity (body mass index >29 kg/m2)
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491319


Sponsors and Collaborators
Nitte University
Investigators
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Study Director: Sripada Mehandale, MBBS, MD Associate Professor

Publications of Results:
Other Publications:
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Responsible Party: Dr. Sara Jaison, Junior Resident, Nitte University
ClinicalTrials.gov Identifier: NCT03491319    
Other Study ID Numbers: nitteU
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Sara Jaison, Nitte University:
Anesthetics, Local
Head-Down Tilt
Anesthesia, Spinal
hypotension
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs