Clinical trial NCT03491319: Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia - A Randomised Controlled Study
Official title: Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia - A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head-Down Tilt Following Spinal Anesthesia
Keywords: Anesthetics, Local
Head-Down Tilt
Anesthesia, Spinal
hypotension
Lead sponsor: Nitte University
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly allocated to one of the 3 groups by closed envelope method
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Maximum height of block
timeFrame: from 5 minutes to 150 minutes after intrathecal injection
measure: Two segment regression time
timeFrame: from 5 minutes to 150 minutes after intrathecal injection
Secondary outcomes:
measure: Hypotension
timeFrame: 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
measure: Tachycardia
timeFrame: 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.
measure: Bradycardia
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor
name: Sripada Mehandale, MBBS, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1136/bmj.321.7275.1493.
citation: Sinclair 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.
citation: 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.
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. doi: 10.1093/bja/ael370. Epub 2007 Feb 5.
citation: Hocking 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.
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. doi: 10.1213/00000539-199303000-00017.