Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery

NCT ID: NCT06342076

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.

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

\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This prospective, randomized study was conducted at Başakşehir Çam and Sakura City Hospital in accordance with the Declaration of Helsinki. After ethics committee approval (decision no: 2023-596, date: 22.11.2023) and written consent from all patients, the study was conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. In the study, which included a total of 50 patients, the patients were divided into two groups: subcostal transversus abdominis plane block (STAPB) or rectus sheath block (RSB). Postoperative 24-hour VAS values, opioid demand and administration amounts in intravenous patient-controlled analgesia, presence of nausea and vomiting, surgical complications and length of hospital stay were evaluated (6th hour, 12th hour, 24th hour).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Postoperative Complications Analgesia Regional Anesthesia Morbidity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomize study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Prospective randomize study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group1: Subcostal transversus abdominis plane block(STAPB)

Subcostal transversus abdominis plane block(STAPB)

Group Type EXPERIMENTAL

Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block

Intervention Type PROCEDURE

To prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer.

Patients undergoing rectus sheat block and posterior transversus abdominis plane block

Intervention Type PROCEDURE

To prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer.

Group 2: Rectus sheat block(RSB)

Rectus sheat block(RSB)

Group Type EXPERIMENTAL

Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block

Intervention Type PROCEDURE

To prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer.

Patients undergoing rectus sheat block and posterior transversus abdominis plane block

Intervention Type PROCEDURE

To prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block

To prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer.

Intervention Type PROCEDURE

Patients undergoing rectus sheat block and posterior transversus abdominis plane block

To prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>18 years
* ASA II-III

Exclusion Criteria

* Those who are allergic to local anesthetics
* BMI\> 40 kg/m2
* Those with chronic pain
* Those with a history of previous abdominal surgery
* Patients who refuse the use of postoperative patient-controlled analgesia
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Duygu Akyol

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.

Reference Type RESULT
PMID: 24882606 (View on PubMed)

Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

Reference Type RESULT
PMID: 20830871 (View on PubMed)

Yorukoglu HU, Sahin T, Oge Kula A. Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Caesarean Delivery: A Randomised Controlled Trial. Turk J Anaesthesiol Reanim. 2023 Feb;51(1):43-48. doi: 10.5152/TJAR.2023.22724.

Reference Type RESULT
PMID: 36847318 (View on PubMed)

Soliz JM, Lipski I, Hancher-Hodges S, Speer BB, Popat K. Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. Anesth Pain Med. 2017 Oct 20;7(5):e12923. doi: 10.5812/aapm.12923. eCollection 2017 Oct.

Reference Type RESULT
PMID: 29696110 (View on PubMed)

Abdelsalam K, Mohamdin OW. Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study. Saudi J Anaesth. 2016 Jan-Mar;10(1):25-8. doi: 10.4103/1658-354X.169470.

Reference Type RESULT
PMID: 26955306 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-596

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IPP-PSP Block vs. SPSIPB in Breast Surgery
NCT07246720 NOT_YET_RECRUITING NA