## Protocol Section
### Identification Module
**NCT ID:** NCT06417203

**Brief Title:** Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty

**Official Title:** Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty Surgeries? Can an Answer be Found by Perfusion Index?

#### Organization Study ID Info
**ID:** 11.05.2024-ADYU-ANS-NY-05
#### Organization
**Class:** OTHER
**Full Name:** Adiyaman University Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Adiyaman University Research Hospital

#### Responsible Party

**Investigator Affiliation:** Adiyaman University Research Hospital

**Investigator Full Name:** Nezir Yılmaz

**Investigator Title:** Associate Professor,MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study was to compare the effects of hypobaric and hyperbaric spinal applications on patient haemodynamics, duration of anaesthetic effect and postoperative analgesia. Thus, it was aimed to determine the method that protects haemodynamics more and suppresses postoperative pain complaints of patients better in this patient group with advanced age, comorbid systemic diseases and high risk of operation.

**Detailed Description:** Patients who are planned to be operated for partial hip replacement at Adıyaman University Training and Research Hospital, who are informed about the study and who agree to participate in the study with their written consent will be included in the study.

Patients who agree to participate in the study will be divided into two groups: hypobaric and hyperbaric spinal anaesthesia patients will be divided into two groups to be decided by the Anaesthesiology and Reanimation specialist responsible for the operation (hyperbaric/hypobaric). Before the start of the operation, perfusion index (PI) values will be monitored with a probe in both lower extremities with standard ASA monitoring. Haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), PI values of both extremities, duration of motor and sensory block, postoperative numeric pain scores of all patients will be recorded and these values will be compared in both groups.

Thus, it was aimed to compare the efficacy, safety, block times and contribution to pain management of each application.

### Conditions Module

**Conditions:**

- Post Operative Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** two gropus planned for study

1. group - Hyperbaric spinal anesthesia
2. group - Hypobaric spinal anesthesia

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** for patient - closed envelope system for Outcomes Assessor - will not participate perioperative period and will not know group of patients

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In this group, hyperbaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery

**Intervention Names:**

- Procedure: spinal anesthesia with hyberbaric bupivacaine

**Label:** Hyberbaric group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In this group, hypobaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery

**Intervention Names:**

- Procedure: spinal anesthesia with hypobaric bupivacaine

**Label:** Hypobaric group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hyberbaric group

**Description:** After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 12.5 mg hyperbaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space.

**Name:** spinal anesthesia with hyberbaric bupivacaine

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Hypobaric group

**Description:** After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 12.5 mg hyperbaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space.

**Name:** spinal anesthesia with hypobaric bupivacaine

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** a tool that asses patinet paiin level 0 (no pain) -10 (the worst pain ever had) , the tool will be used at postopertaive period

**Measure:** Visual analog pain score (VAS)

**Time Frame:** three months

#### Secondary Outcomes

**Description:** a tool that asses recovery quality of patient with 15 question will be used 24th hour after surgery

**Measure:** Quality of recovery (QoR-15)

**Time Frame:** Three months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I-II

Exclusion Criteria:

* ASA III-IV
* Deny to participiate
* conditions that spinal anesthesia contraindicated

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yilmaznezirr@gmail.com

**Name:** Nezir Yılmaz

**Phone:** 05068939496

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Adıyaman

**Country:** Turkey

**Facility:** Adıyaman Training and Research Hospital

**Zip:** 02200

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
