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Does adjusting the dose of spinal anaesthetic for patient height improve the reliability of spinal anaesthesia?

A randomised controlled trial comparing an individualised, height–related dose of intrathecal 0.5% hyperbaric bupivacaine with the standard fixed dose of 2.6 ml, for elective Caesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13247823
Enrollment
200
Registered
2023-02-22
Start date
2022-11-01
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal anaesthesia for elective Caesarean section Pregnancy and Childbirth

Interventions

The study will run from the participant giving consent on the morning of surgery, until discharge. At the University Hospital of North Durham, a height-related dose of 0.5% hyperbaric bupivacaine has

Sponsors

County Durham and Darlington NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Height of = 150cm and = 160cm or = 165cm and = 175cm (rounded to nearest cm) 2. Elective Caesarean section 3. Singleton pregnancy 4. Gestation 36 weeks or greater 5. American Society of Anesthesiologists (ASA) physical status II (appendix 6) with the exception for term BMI = 40 6. No known foetal abnormalities

Exclusion criteria

Exclusion criteria: 1. Height 175 cm (rounded to nearest cm) 3. Height = 161 cm and = 164 cm (rounded to nearest cm). 4. Age 50 7. Anterior or posterior placenta praevia 8. ASA physical status III or greater (appendix 6) with the exception for term BMI = 40 9. Patients with pre -existing (essential) hypertension or pregnancy –induced hypertension 10. Contraindication or refusal for spinal anaesthesia 11. Any neurological disease 12. Any spinal cord abnormality 13. Any vertebral column abnormality, such as scoliosis 14. Congenital or acquired short limbs or any other lower limb abnormality causing a reduction in height 15. Patients receiving any medications affecting the cardiovascular system 16. Any additional surgery planned (with the exception of bilateral tubal ligation) 17. Pre-existing major abdominal pathology (fibroids, significant ovarian cyst) 18. Known allergy to bupivacaine, fentanyl or morphine 19. Patients under the care of His Majesty’s Prison 20. Patients who lack capacity 21. Patients who require an interpreter for communication

Design outcomes

Primary

MeasureTime frame
1. Proportion of patients at the median block height measured using cold sensation with ethyl chloride spray, for each group, +/- one dermatome, at ten min post-spinal injection 2. Proportion of patients with a block height of T2, T3 or T4 measured using cold sensation with ethyl chloride spray, at ten min post spinal injection

Secondary

MeasureTime frame
1. Sensory block height measured using cold sensation with ethyl chloride spray: 1.1. The mean (or median, if skewed distribution) block height at 10, 15 and 20 min post spinal injection (with surgery allowed to start at block height T4) 1.2. Time to reach a T4 inclusive block or above (10, 15 or 20 min) 1.3. Maximum block height achieved up to 20 min post spinal injection 1.3.1 Proportion of patients with a maximum block height within the target range of T2-T4 by 20 min 1.3.2. Proportion of patients with a maximum block above the target range of T2-T4 by 20 min; T1 is relatively high and C8 or higher is high 1.3.3. Proportion of patients with a maximum block height below the target range of T2-T4 by 20 min; T5 is relatively low and T6 or below is low 1.4. Failure of block: Block not considered satisfactory to proceed by 20 min post spinal injection (even if subsequently evolves so surgery can start), or epidural or general anaesthetic required, or surgical testing inadequate (allowing up to 20 min from spinal injection) 1.5. Proportion of patients blocked to T4 bilaterally at 10 min 1.6. Necessity to alter patient position to achieve target block height (position used and time in min) 2. Motor block measured using the Bromage score at 10, 15 and 20 min post spinal injection 3. Time from spinal injection to return of motor function measured by a Bromage Motor Blockade score of 4 4. Time from spinal injection to regression of cold sensation to dermatome level T10 5. Symptoms of a high subarachnoid block measured by documenting hand grasp weakness, altered mental status and respiratory distress post-spinal injection 6. Symptoms of an inadequate block measured by documenting pain and poor muscle relaxation post-spinal injection 7. Intraoperative pain measured by quantifying analgesic supplementation and using a numerical rating score 8. Postoperative pain measured using a numerical rating score 9. Systolic arterial pressure (SAP) measured using a sphygmomanome

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026