To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP

NCT05285800 | Completed Phase 3 DMC

• 1 other identifier: W0333
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effectiveness of saddle block vs spinal anesthesia in TURP.

Conditions

Haemodynamic Instability

Outcome Measures

Primary Outcomes (2)

• Haemodynamic status

  Haemodynamic status includes pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation. Pulse rate ranges between 60-100 beats/ minute. Pulse above 100 is called tachycardia and below 60 is called bradycardia Systolic blood pressure more than 140mmhg is called systolic hypertension and lower than 90mmhg is known as systolic hypotension. Diastolic blood pressure more than 90mmhg is called diastolic hypertension and lower than 60mmhg is called diastolic hypotension. Mean arterial pressure ranges between 70-110. More than 110 labeled as hypertension and below 70 means hypotension. Spo2 level below 94% is labeled as hypoxia.

  Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.

• Vasopressor usage

  The main side effect of intrathecal 0.5 % hyperbaric Bupivacaine is hypotension. That is countered by using vasopressor drug e.g inj. Ephedrine. Critically low blood pressure e.g systolic bp below 90mmhg, diastole c blood pressure below 60mmh and MAP below 60 is an indication for vasopressor introduction.

  Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery

Study Arms (2)

Saddle group

EXPERIMENTAL

After administration of 12mg of 0.5 % Hyperbaric Bupivacaine intrathecally, Patient is advised to remain in Sitting position for the next 5minutes and then take supine position

Drug: 0.5% Hyperbaric Bupivacaine

Spinal group

ACTIVE COMPARATOR

After administration of 12mg of 0.5% Hyperbaric Bupivacaine intrathecally, Patient is advised to take Supine position immediately.

Drug: 0.5% Hyperbaric Bupivacaine

Interventions

0.5% Hyperbaric Bupivacaine DRUG

In both groups 0.5% Hyperbaric Bupivacaine is given intrathecally and then saddle group is advised to stay in sitting position for next 5minutes so that drug can block only lower segments of nerves, Lumber 5th to Sacral dermatomes level. The spinal group is advised to take supine position immediately so that drug distribution be uniform uptill T10 level of spinal dermatome. Then outcomes regarding haemodynamic status and vasopressor usage are recorded

Also known as: Hyperbaric Bupivacaine

Saddle group; Spinal group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with absolute contraindication of general anaesthsia
• Patients who gave consent and willing to be included in study
• Patient's having age range between 45 years to 65years
• Well controlled diabetes and hypertension
• ASA grade I \& II

You may not qualify if:

• Patients with absolute contraindications of regional anesthesia,
• Deformity of vertebral column,
• Thyroid disorder,
• Psychiatric illness,
• Neurological diseases,
• Alcohol addiction,
• Smoking,
• Ischemic heart diseases and
• Not willing to participate

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Dr. Muhammad Wajid Iqbal

Karachi, Sindh, 74600, Pakistan

Location

Study Officials

• Dr. Wajid Iqbal, MBBS, MCPS

  Hamdard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident medical officer, Anesthesiology

Model Details: In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 18, 2022
• Study Start: September 6, 2021
• Primary Completion: March 6, 2022
• Study Completion: March 6, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)