## Protocol Section
### Identification Module
**NCT ID:** NCT06427551

**Acronym:** volupeng

**Brief Title:** Volume Effect in Peng Block for Total Hip Replacement

**Official Title:** Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications

#### Organization Study ID Info
**ID:** VOLUPENG
#### Organization
**Class:** OTHER
**Full Name:** Azienda Ospedaliero, Universitaria Pisana
### Status Module
#### Completion Date
**Date:** 2024-01-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Azienda Ospedaliero, Universitaria Pisana

#### Responsible Party

**Investigator Affiliation:** Azienda Ospedaliero, Universitaria Pisana

**Investigator Full Name:** Serena Ricalzone

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.

**Detailed Description:** patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery

### Conditions Module

**Conditions:**

- Anesthesia

- Post Operative Pain

**Keywords:**

- postoperative

- orthopedic surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** in this group of patients the peng block was performed with 15 ml of ropivacaine, whose dose was obtained on the weight

**Intervention Names:**

- Drug: Ropivacaine

**Label:** 15 ml local anesthetic

#### Arm Group 2

**Description:** in this group of patients the peng block was performed with 20 ml of ropivacaine, whose dose was obtained on the weight

**Intervention Names:**

- Drug: Ropivacaine

**Label:** 20 ml local anesthetic

#### Arm Group 3

**Description:** in this group of patients the peng block was performed with 30 ml of ropivacaine, whose dose was obtained on the weight

**Intervention Names:**

- Drug: Ropivacaine

**Label:** 30 ml local anesthetic

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 15 ml local anesthetic

- 20 ml local anesthetic

- 30 ml local anesthetic

**Description:** The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg)

**Name:** Ropivacaine

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours

**Measure:** presence of side effects

**Time Frame:** 24 hours

**Description:** requirement of analgesic to control the pain, assessed every six hours

**Measure:** analgesic requirements

**Time Frame:** 24 hours

#### Primary Outcomes

**Description:** Evaluate pain for every volume group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three.

Success of the block was defined as NRS≤3.

**Measure:** NRS evaluation

**Time Frame:** 24h post-op

#### Secondary Outcomes

**Description:** consider variation of pain, assessed with numeric Pain scale, for each group, every six hours

**Measure:** NRS variation in time

**Time Frame:** 24 h

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I, ASA II, ASA III
* Age≥18
* Total hip replacement surgery in spinal anesthesia
* Informed consent

Exclusion Criteria:

* ASA IV
* INR\>1.3
* platelet values\<100\*10\^3/ml a
* patients on anticoagulant or antiplatelet therapy
* general anesthesia for total hip replacement surgery
* patients on chronic opioid therapy
* altered sensitivity or motility
* Patients in chronic opioid therapy
* Refuse to sign informed consent form
* Unable to sign informed consent form
* Know allergies to medication used for analgesia

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients underwent total hip replacement in elective surgery

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pisa

**Country:** Italy

**Facility:** Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello

**State:** Toscana

**Zip:** 56124

#### Overall Officials

**Official 1:**

**Affiliation:** aoupisa

**Name:** manuela nicastro, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- 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: D000000777

- Term: Anesthetics

- 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: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M1700

- Name: Ropivacaine

- Relevance: HIGH

- As Found: Eye

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077212

- Term: Ropivacaine

### Misc Info Module

- Version Holder: 2024-05-31
