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

Head-Down Tilt Following Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491319
• Other study ID #: nitteU
• Status: Completed
• Phase: N/A
• First received: March 31, 2018
• Last updated: March 31, 2018
• Start date: October 1, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: July 2017
• Source: Nitte University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Head-Down Tilt Following Spinal Anesthesia

Intervention

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
• 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
• Group C - neutral
spinal anaesthesia was given with table in neutral positon. Patient was maintained in supine position for 10 minutes following spinal anaesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nitte University

References & Publications (6)

Dixit 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. — View Citation

Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. Epub 2004 Jun 25. Review. — View Citation

Kim 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. Epub 2007 Feb 5. — View Citation

Miyabe M, Namiki A. The effect of head-down tilt on arterial blood pressure after spinal anesthesia. Anesth Analg. 1993 Mar;76(3):549-52. — View Citation

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. Review. — View Citation

Sinclair CJ, Scott DB, Edström HH. Effect of the trendelenberg position on spinal anaesthesia with hyperbaric bupivacaine. Br J Anaesth. 1982 May;54(5):497-500. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum height of block		from 5 minutes to 150 minutes after intrathecal injection
Primary	Two segment regression time	time from injection of spinal drug to regression of the sensory block by two segments from the maximum	from 5 minutes to 150 minutes after intrathecal injection
Secondary	Hypotension	drop in systolic blood pressure to less than 30% of baseline values or systolic blood pressure (SBP) below 90mmHg	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
Secondary	Tachycardia	heart rate more than 100bpm or increase by more than 30% over baseline value.	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.
Secondary	Bradycardia	heart rate less than 50bpm or decrease by more than 30% below baseline value.	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