Height Versus Height and Weight Based Spinal Bupivacaine on Maternal Haemodynamics for Elective Cesarean in Short Stature Patients

NCT ID: NCT04082676

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2021-09-01

Brief Summary

Doses of intrathecal bupivacaine based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.

In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients. Therefore, our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.

Detailed Description

Spinal induced hypotension in women undergoing caesarean section (CS) is the most common unwanted effect. The dose of intrathecal local anesthetic is the main determining factor that balances between successful block and an incidence of maternal hypotension. Although lowering the doses of intrathecal bupivacaine provides better maternal hemodynamic stability it compromises the quality of anesthesia. Moreover, there is no consensus regarding the cut-off at which the dose can be defined as low. Doses based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.

In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients.

Our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.

Doses of intrathecal bupivacaine for elective caesarean section based on Harten chart is available from the following reference- Harten JM, Boyne I, Hannah P, Varveris D, Brown A. Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section. Anaesthesia 2005; 60: 348-53.

Consent for the participation in the study will be obtained during pre-anaesthetic assessment visits in the evening before surgery. The investigator will also educate the patients regarding the use of numeric rating scale scores. Preoperative anxiety will be recorded in numerical rating scale scores where 0 is no anxiety and 10 is maximum anxiety patient reported. The enrolled subjects will be randomly assigned to 2 equal groups (allocation ratio, 1:1) according to the codes generated from the website (www.sealedenvleop.com) using the variable block size of 4, 6 and 8. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes that will be opened by the anaesthesia assistant not involved in the study only after the patient arrives in the operating room. The patient will be fasted for at least eight hours and will receive antibiotics, ranitidine 50 mg and metoclopramide 10 mg intravenously via 18-gauge cannula before transfer to the operation room. In the operating table patient will be laid supine with a wedge under right buttock and standard monitors (electrocardiography, pulse oximetry, and noninvasive BP) will be applied. Thereafter, successive three readings of heart rate (HR) and systolic blood pressure (SBP) will be taken at 2 minutes interval with difference not exceeding 10%. The average of these recordings will be documented by the investigators as baseline parameters. To maintain blinding, the investigator will leave the operating room and will return immediately once the spinal injection is initiated. Subarachnoid block will be performed by the attending anesthesiologist not involved in the study in the sitting position at the L3-L4 or L4-L5 vertebral interspace using a 25-gauge spinal needle via midline approach. The study solution will be administered according to the group allocated. In Group A the dose of heavy bupivacaine will be based on height and weight and in group B the dose will be based on patient's height (0.06 mg/cm). 10 microgram fentanyl will be added to bupivacaine in both groups.

Conditions

Maternal Hypotension After Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Height and weight based group

Patients in "Height and weight based group" will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml)

Group Type: EXPERIMENTAL

Hyperbaric bupivacaine spinal

Intervention Type: DRUG

In this group patient will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml)

Height based group

Patients in "Height based group" will receive intrathecal hyperbaric bupivacaine based on patients height i.e. (0.06mg/cm) with 10 μg of fentanyl (0.1 ml)

Group Type: ACTIVE_COMPARATOR

Hyperbaric bupivacaine spinal

Intervention Type: DRUG

In this group will receive intrathecal hyperbaric bupivacaine based on patients height (0.06mg/cm) with 10 μg of fentanyl (0.1 ml)

Interventions

Hyperbaric bupivacaine spinal

In this group patient will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml)

Intervention Type: DRUG

Hyperbaric bupivacaine spinal

In this group will receive intrathecal hyperbaric bupivacaine based on patients height (0.06mg/cm) with 10 μg of fentanyl (0.1 ml)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women with full-term gestation undergoing planned Caesarean section under spinal anesthesia
• Who provide consent .
• Height less than 150 cm

Exclusion Criteria

• Patients with height <140 cm,
• Hypertensive disorders of pregnancy,
• Placental disorders,
• Body mass index ≥ 40 kg/m2,
• Diabetes mellitus
• Cardiovascular
• Cerebrovascular
• Hormonal disorder
• Renal disease
• Polyhydramnios
• Known case of bad obstetric history
• Fetal abnormalities
• Baseline systolic blood pressure (SBP) less than 100 mmHg
• Contraindication to spinal anaesthesia
• Allergy to any drug used in the study and
• Those unable to understand and sign the consent form

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr Asish Subedi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asish Subedi, MD

Role: PRINCIPAL_INVESTIGATOR

B.P. Koirala Institute of Health Sciences

Locations

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, Nepal

Countries

Nepal

References

Subedi A, Thapa P, Prajapati R, Schyns-van den Berg AMJV. Effect of height versus height/weight-based spinal bupivacaine on maternal hemodynamics for elective cesarean in short stature patients: a randomized clinical trial. J Anesth. 2023 Dec;37(6):905-913. doi: 10.1007/s00540-023-03252-x. Epub 2023 Sep 14.

Reference Type: DERIVED

PMID: 37709952 (View on PubMed)

Other Identifiers

IRC/1525/019

Identifier Type: -

Identifier Source: org_study_id