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NCT Number: NCT06342076

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

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.

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Key information

Conditions

Postoperative Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Regional Anesthesia Morbidity Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

Primary outcomes

  1. visuel analog scale

    Time frame: 24 hours postoperatively

    Our primer aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Numeric Rating Scale(NRS) was used to assess postoperative pain.6th, 12th, 24th hour NRS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Secondary outcomes

  1. amount of opioid used

    Time frame: 24 hours postoperatively

    Our secondary aim was to evaluate the opioid amount (mg) in the first 24 hours of intravenously administered opioids with patient-controlled analgesia.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Comparison of the Efficacy of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block for Postoperative Analgesia in Major Open Gynaecological Cancer Surgery: a Prospective Randomised Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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