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

NCT03491319 | Completed DMC

• 1 other identifier: nitteU
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head-Down Tilt Following Spinal Anesthesia

Keywords

Anesthetics, Local; Head-Down Tilt; Anesthesia, Spinal; hypotension

Outcome Measures

Primary Outcomes (2)

• Maximum height of block

  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

  from 5 minutes to 150 minutes after intrathecal injection

Secondary Outcomes (3)

• Hypotension

  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

  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

  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

Study Arms (3)

Group C Control

PLACEBO COMPARATOR

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

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

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

Procedure: Group Y - head low tilt

Interventions

Group X - head low tilt PROCEDURE

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

Group X

Group Y - head low tilt 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

Group Y

Group C - neutral PROCEDURE

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

Group C Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nitte University: lead

Related Publications (6)

• 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.

  PMID: 11118174 BACKGROUND

• 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.

  PMID: 7073918 BACKGROUND

• 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.

  PMID: 26955307 BACKGROUND

• 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.

  PMID: 17283005 BACKGROUND

• 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.

  PMID: 15220175 RESULT

• 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.

  PMID: 8452265 RESULT

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sripada Mehandale, MBBS, MD

  Associate Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

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

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: April 9, 2018
• Study Start: October 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: April 9, 2018

Record last verified: 2017-07