Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia

NCT01321684

Spinal Anesthesia

COMPLETED NA

The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia

NCT06293404

Hip Fractures Spinal Anesthesia

NOT_YET_RECRUITING NA

A Comparative Analysis of Combined Superficial Cervical Plexus and Supraorbital Blocks Compared to Scalp Blocks During Craniotomy: a Review of Opioid Consumption and The Suppression of Hemodynamic Responses

NCT07131046

Craniotomy Surgery Regional Anaesthesia Scalp Block +1 more

COMPLETED NA

Pre-post Spinal Popliteal Block

NCT05354791

Foot Surgery Ankle Surgery

TERMINATED

Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade

NCT00802581

Sciatic Nerve Blockade for Foot/Ankle Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head-Down Tilt Following Spinal Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly allocated to one of the 3 groups by closed envelope method

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group C Control

spinal anaesthesia was given with table in neutral positon. Same position was maintained after spinal anaesthesia

Group Type PLACEBO_COMPARATOR

Group C - neutral

Intervention Type PROCEDURE

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

Group X

spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal

Group Type ACTIVE_COMPARATOR

Group X - head low tilt

Intervention Type PROCEDURE

spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal anaesthesia

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

Group Type ACTIVE_COMPARATOR

Group Y - head low tilt

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes