## Protocol Section
### Identification Module
**NCT ID:** NCT06424938

**Brief Title:** Postoperative Analgesia in Major Gynecological Cancer Surgeries

**Official Title:** The Effect of Epidural Analgesia and Erector Spinae Plane Block on Intraoperative and Early Postoperative Outcomes in Open Gynecological Oncological Surgeries: a Prospective Randomized Study

#### Organization Study ID Info
**ID:** 2023-597
#### Organization
**Class:** OTHER_GOV
**Full Name:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital
### Status Module
#### Completion Date
**Date:** 2025-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-13

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Duygu Akyol

#### Responsible Party

**Investigator Affiliation:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital

**Investigator Full Name:** Duygu Akyol

**Investigator Title:** M.D

**Type:** SPONSOR_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 is to compare the effectiveness of epidural block or erector spinae plane block applied for postoperative analgesia in gynecological cancer surgeries.

The main question(s) it aims to answer are:

\[Is erector spinae plane block as effective as epidural block in postoperative analgesia?\] The study was designed as a prospective randomized study. Researchers evaluated the effects of epidural block or erector spinae plane block applied for postoperative analgesia on pain scores, postoperative opioid use, and mobilization in patients undergoing gynecological cancer surgery.

**Detailed Description:** Our study was designed as a prospective randomized study. The investigators evaluated the analgesia methods used in patients undergoing surgery for gynecologic cancer between May 2024 and December 2024. The investigators evaluated the effect of epidural block or erector spina plan block on postoperative analgesia, opioid use and mobilization.

Group 1: Epidural block group Group 2: Group with erector spina plan block

### Conditions Module

**Conditions:**

- Analgesia

- Analgesia, Epidural

- ERAS

**Keywords:**

- postoperative analgesia

- periferic nerve block

- neuraxial block

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study was designed as a prospective randomized study. Patients with ASA II-III between the ages of 30 and 70 who will undergo major gynecological cancer surgery will be included in the study. They will be randomized into 2 groups: the group in which epidural block is applied for postoperative analgesia (Group Epidural) and the group in which erector spinae plane block is applied (Group ESP).

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The group in which epidural block is applied for postoperative analgesia (Group Epidural)

**Intervention Names:**

- Procedure: Patients who underwent epidural block

- Procedure: Patients who underwent erector spina plane block

**Label:** The group in which epidural block

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The group in which erector spinae plane block is applied (Group ESP)

**Intervention Names:**

- Procedure: Patients who underwent epidural block

- Procedure: Patients who underwent erector spina plane block

**Label:** The group in which erector spinae plane block

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- The group in which epidural block

- The group in which erector spinae plane block

**Description:** The researchers administered an epidural block to prevent post-operative pain to the epidural block group undergoing midline incision surgery for major gynecologic cancer.

**Name:** Patients who underwent epidural block

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- The group in which epidural block

- The group in which erector spinae plane block

**Description:** Researchers applied a erector spina plane block to prevent postoperative pain to the erector spina plane block group undergoing midline incision surgery for major gynecological cancer.

**Name:** Patients who underwent erector spina plane block

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** The other purpose of this study is the first postoperative mobilization process

**Measure:** postoperative mobilization time

**Time Frame:** postoperatvely 24 hours

#### Primary Outcomes

**Description:** The primary purpose of this study is to compare NRS values at 0, 6, 12 and 24 hours in the first 24 hours postoperatively. Numeric rating scale was used to assess postoperative pain For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

**Measure:** postoperative numerical rating scale

**Time Frame:** postoperatvely 24 hours

#### Secondary Outcomes

**Description:** The secondary aim of this study is to compare the amount of intraoperative remifentanyl

**Measure:** Intraoperative amount of remifentanyl

**Time Frame:** intraoperative process

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients who will undergo open abdominal surgery
* Patients with ASAII-III
* Those between the ages of 30-70
* Patients who are fully oriented and able to cooperate

Exclusion Criteria:

* Patients with ASAIV-V
* Presence of active infection in the area where the block will be applied
* Patients younger than 30 years old
* Patients with BMI \&gt; 40
* Patients who are allergic to bupivacaine
* Chronic analgesic use

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 30 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dr.duyguaygun@gmail.com

**Name:** Duygu Akyol, M.d

**Phone:** +905447616034

**Role:** CONTACT

**Contact 2:**

**Email:** cerenganidagli@gmail.com

**Name:** Ceren Ganidağlı, M.d

**Phone:** +905319301828

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.

**PMID:** 37086524

**Citation:** Bisch SP, Jago CA, Kalogera E, Ganshorn H, Meyer LA, Ramirez PT, Dowdy SC, Nelson G. Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis. Gynecol Oncol. 2021 Apr;161(1):46-55. doi: 10.1016/j.ygyno.2020.12.035. Epub 2020 Dec 30.

**PMID:** 33388155

**Citation:** Courtney-Brooks M, Tanner Kurtz KC, Pelkofski EB, Nakayama J, Duska LR. Continuous epidural infusion anesthesia and analgesia in gynecologic oncology patients: less pain, more gain? Gynecol Oncol. 2015 Jan;136(1):77-81. doi: 10.1016/j.ygyno.2014.10.015. Epub 2014 Oct 23.

**PMID:** 25449564

**Citation:** Chen LM, Weinberg VK, Chen C, Powell CB, Chen LL, Chan JK, Burkhardt DH 3rd. Perioperative outcomes comparing patient controlled epidural versus intravenous analgesia in gynecologic oncology surgery. Gynecol Oncol. 2009 Dec;115(3):357-61. doi: 10.1016/j.ygyno.2009.08.015. Epub 2009 Sep 23.

**PMID:** 19783285

**Citation:** Ferguson SE, Malhotra T, Seshan VE, Levine DA, Sonoda Y, Chi DS, Barakat RR, Abu-Rustum NR. A prospective randomized trial comparing patient-controlled epidural analgesia to patient-controlled intravenous analgesia on postoperative pain control and recovery after major open gynecologic cancer surgery. Gynecol Oncol. 2009 Jul;114(1):111-6. doi: 10.1016/j.ygyno.2009.03.014. Epub 2009 Apr 23.

**PMID:** 19395071

**Citation:** Lin C, Gill R, Kumar K. [Bilateral lower thoracic erector spinae plane block in open abdominal gynecologic oncology surgery: a cases series]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):517-520. doi: 10.1016/j.bjan.2019.03.011. Epub 2019 Oct 19.

**PMID:** 31635757

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010468

- Term: Perceptual Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3727

- Name: Agnosia

- Relevance: HIGH

- As Found: Analgesia

- ID: M13379

- Name: Perceptual Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T241

- Name: Agnosia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000377

- Term: Agnosia

### Misc Info Module

- Version Holder: 2024-05-31
