The Effects of Abdominal Plane Blocks on Postoperative Quality of Recovery

March 6, 2025 updated by: İnan SARIDEDE, Fatih Sultan Mehmet Training and Research Hospital

The Effects of Ultrasound-Guided Abdominal Plane Blocks on Postoperative Pain and Quality of Recovery in Laparoscopic Inguinal Hernia Repair

In laparoscopic inguinal hernia surgeries, although the effects of classical transversus abdominis plane (TAP) and Modified thoracoabdominal nerve block through perichondrial approach (m-TAPA) blocks on perioperative pain control and opioid consumption have been evaluated in various studies using classical scaling methods, their impact on postoperative recovery quality remains an area open for further research. In this observational study, the investigator's primary goal is to evaluate the effects of lateral approach TAP and m-TAPA blocks, which are routinely used for postoperative analgesia, on postoperative pain and recovery quality in patients undergoing laparoscopic inguinal hernia surgery, using the QoR-15 scale. The investigator's secondary goal is to contribute to identifying the standard analgesia method that will reduce postoperative opioid use, nausea, and vomiting, and improve recovery quality.

Study Overview

Status

Completed

Conditions

Detailed Description

Laparoscopic surgery is widely used in the repair of inguinal hernias, but it can cause moderate to severe postoperative pain. Perioperative pain management is essential for ensuring early mobilization of patients, reducing postoperative side effects and hospital stay durations, improving patient satisfaction, and preventing the development of chronic pain after surgery. The quality of postoperative recovery is influenced by various factors, such as the patient's preoperative characteristics, the type of surgery, the level of postoperative pain, and analgesic methods. In recent years, alongside traditional scales measuring classical parameters in evaluating postoperative recovery quality, new measurement tools focusing on patient satisfaction have been developed. One of these tools is the Quality of Recovery-15 (QoR-15) scale, which has been recommended by the European Society of Anaesthesiology for use in clinical studies investigating postoperative patient comfort and pain levels. This scale includes 15 questions across five different areas evaluating postoperative recovery from various perspectives: pain, physical comfort, physical independence, psychological support, and emotional state. The result is a score between 0 and 150, with higher scores indicating better recovery quality.

Ultrasound (USG)-guided abdominal plane blocks are an important part of multimodal analgesia due to their ease of application, ability to provide long-lasting postoperative analgesia, and potential to reduce opioid consumption. Various regional anesthesia techniques can be used for pain control following laparoscopic inguinal hernia repair surgeries (TransAbdominal Pre-Peritoneal approach-TAPP). Some of these techniques include the Transversus Abdominis Plane (TAP) block and the Perichondrial Approach Modified Thoracoabdominal Plane (m-TAPA) block. The TAP block is performed in the neurofascial plane between the internal oblique and transversus abdominis muscles, creating a dermatomal sensory block at the T6-L1 levels. It can be applied laterally, subcostally, or posteriorly. The Perichondrial Approach Modified Thoracoabdominal Plane (m-TAPA) block is used more recently in upper and lower abdominal surgeries to provide effective analgesia due to its wider dermatomal coverage. The m-TAPA block is performed under ultrasound guidance by injecting a local anesthetic between the costal cartilage and the transversus abdominis muscle, providing abdominal analgesia from T4-L1 along the anterior and lateral abdominal wall. Both TAP and m-TAPA blocks are regional analgesia techniques commonly applied in our daily practice after abdominal surgeries. The choice of regional anesthesia technique is determined based on the surgical region, type of surgery, and the experience of the anesthesia team.

This study includes 60 patients aged 18-65 years, classified in the American Society of Anesthesiologists (ASA) physical risk class I-III, who are scheduled to undergo elective laparoscopic inguinal hernia repair surgery under general anesthesia at the General Surgery Department of Fatih Sultan Mehmet Training and Research Hospital.Participants who are planning to receive M-TAPA block defines as Group M-TAPA, and those who receive lateral TAP block defines as Group TAP, with 30 patients in each group. After obtaining ethical approval on 14.12.2023, patients will be informed about the study procedure one day before surgery, and those who consent will sign an informed consent form. The QoR-15 questionnaire, used to assess anesthesia and surgical recovery quality, will be administered to patients preoperatively, 24 hours post-surgery, and on the 15th postoperative day. The results will be recorded for further analysis.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34752
        • Fatih Sultan Mehmet Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who will undergo laparoscopic unilateral inguinal hernia surgery under general anesthesia in elective conditions.

Description

Inclusion Criteria:

  • Patients who will undergo laparoscopic unilateral inguinal hernia surgery under general anesthesia in elective conditions, by the General Surgery clinic between January 10, 2024 and October 17, 2024
  • Aged between 18-65 years, with a Body Mass Index (BMI) < 35 kg/m²,
  • Having an American Society of Anesthesiologists (ASA) physical risk score of I-III,
  • Patients who have given informed consent.

Exclusion Criteria:

  • Patients who refuse to participate in the study
  • Emergency surgeries
  • Patients who will undergo recurrent or bilateral surgery
  • Patients with a BMI ≥ 35 kg/m²
  • Presence of local infection or hematoma at the application site
  • Presence of coagulopathy
  • History of known local anesthetic allergy or toxicity
  • Patients with a history of hematological, renal, or hepatic diseases, or advanced respiratory or cardiac failure
  • Patients with difficulty in cooperation, Alzheimer's, dementia, or psychiatric and neurological diseases
  • Patients with a history of chronic analgesic use, chronic alcohol use, or substance addiction
  • Patients who do not speak Turkish or have a language barrier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rate Score (NRS)
Time Frame: During the postoperative period, the NRS scores of patients in motion and at rest will be recorded at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
NRS is a 0 to 10 scale that describes pain from good to worst.
During the postoperative period, the NRS scores of patients in motion and at rest will be recorded at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Quality of recovery-15 (QoR-15) score
Time Frame: The QoR-15 questionnaire will be administered to participants before surgery, 24 hours after surgery, and on the 15th postoperative day.
Quality of Recovery-15 (QoR-15) questionnaire, is used to measure anesthesia and surgical recovery quality
The QoR-15 questionnaire will be administered to participants before surgery, 24 hours after surgery, and on the 15th postoperative day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting scale (PONV)
Time Frame: During the postoperative period, the nausea and vomiting scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
PONV is a 0 to 4 scale that describes nausea and vomiting from good to worst.
During the postoperative period, the nausea and vomiting scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Sedation score
Time Frame: During the postoperative period, the sedation scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Sedation score is a 0 to 3 scale that describes sedation from good to worst.
During the postoperative period, the sedation scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Pain Controlled Analgesia (PCA)
Time Frame: PACU 0,15, 30th minutes and postoperative 2, 4, 6, 12, 24th hours]
PCA includes 200mg Tramadol/100 ml SF- no infusion, 5cc bolus, 15 minutes lock.
PACU 0,15, 30th minutes and postoperative 2, 4, 6, 12, 24th hours]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Study Director: Oznur Demiroluk, Associate Professor, Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Actual)

October 17, 2024

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSMTRH-INAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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