Bilateral Erector Spinal Plan Block in Postoperative Analgesia After Total Abdominal Hysterectomy

Sponsor

Kocaeli University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05513196

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The importance of effective postoperative pain management is well known. Overall, for total abdominal hysterectomy operations are related with severe postoperative pain. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Many regional anesthesia techniques can be preferred for total abdominal hysterectomy. The aim of this study is to investigate postoperative analgesia effect of erector spina plane block for total abdominal hysterectomy.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Erector spinae plane block (ESPB)

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Bilateral Erector Spinal Plan Block in Postoperative Analgesia After Total Abdominal Hysterectomy: An Observational Study

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
ESPB Group Erector spinae plane block performed group.	Procedure: Erector spinae plane block (ESPB) Bilateral erector spinae plane block will be performed with 20 mL, 0.25% bupivacaine at T9 level preoperatively.
Control Group Control group.

Arm

Intervention/Treatment

ESPB Group

Erector spinae plane block performed group.

Procedure: Erector spinae plane block (ESPB)

Bilateral erector spinae plane block will be performed with 20 mL, 0.25% bupivacaine at T9 level preoperatively.

Control Group

Control group.

Outcome Measures

Primary Outcome Measures

Visuel analog scale [Postoperative 24th hour]
visuel analog scale of patients
Morphine consumption [Postoperative 24th hour]
Morphine consumption (mg) of patients with patient controlled analgesia device

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA 1-2 patients
patients undergo elective total abdominal hysterectomy

Exclusion Criteria:

patient refusal
ASA 3-4
obesity (body mass index >35 kg/m2)
infection of the skin at the site of needle puncture area patients
with known allergies to any of the study drugs
coagulopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University	Kocaeli	Izmit	Turkey	41350

Sponsors and Collaborators

Kocaeli University

Investigators

Principal Investigator: engin MD çetin, Kocaeli Universty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Engin Çetin, principal investigator, Kocaeli University

ClinicalTrials.gov Identifier:

NCT05513196

Other Study ID Numbers:

2021-ESP

First Posted:

Aug 24, 2022

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Engin Çetin, principal investigator, Kocaeli University

postoperative pain

total abdominal hysterectomy

erector spinal plan block

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Aug 24, 2022