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

NCT ID: NCT05285800

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2022-03-06

Brief Summary

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

Detailed Description

This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.

Conditions

Haemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Saddle group

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

Group Type: EXPERIMENTAL

0.5% Hyperbaric Bupivacaine

Intervention Type: 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

Spinal group

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

Group Type: ACTIVE_COMPARATOR

0.5% Hyperbaric Bupivacaine

Intervention Type: 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

Interventions

0.5% Hyperbaric Bupivacaine

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

Intervention Type: DRUG

Other Intervention Names

Hyperbaric Bupivacaine

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hamdard University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Muhammad Wajid Iqbal

Resident medical officer, Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Wajid Iqbal, MBBS, MCPS

Role: PRINCIPAL_INVESTIGATOR

Hamdard University

Locations

Dr. Muhammad Wajid Iqbal

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

W0333

Identifier Type: -

Identifier Source: org_study_id