The Effects of Abdominal Plane Blocks on Postoperative Quality of Recovery

NCT06753240 | Completed

• 1 other identifier: FSMTRH-INAN
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Inguinal Hernia Repair; Quality of Recovery (QoR-15); Postoperative Analgesia; Regional Anesthesia

Keywords

laparoscopic inguinal hernia repair; m-tapa block; tap block; quality of recovery; patient controlled analgesia

Outcome Measures

Primary Outcomes (2)

• Numeric Rate Score (NRS)

  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

  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 Outcomes (3)

• Postoperative nausea and vomiting scale (PONV)

  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

  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)

  PACU 0,15, 30th minutes and postoperative 2, 4, 6, 12, 24th hours]

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (5)

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 BACKGROUND

• Ciftci B, Gungor H, Alver S, Akin AN, Ozdenkaya Y, Tulgar S. Clinical Experience for Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Five Patients. Dermatomal Evaluation and Application of Different Volumes: A Case Series and Review of Literature. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):354-357. doi: 10.4274/TJAR.2022.221042.

  PMID: 37587679 BACKGROUND

• Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.

  PMID: 35430086 BACKGROUND

• Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.

  PMID: 36511494 BACKGROUND

• Alver S, Ciftci B, Gungor H, Golboyu BE, Ozdenkaya Y, Alici HA, Tulgar S. Efficacy of modified thoracoabdominal nerve block through perichondrial approach following laparoscopic inguinal hernia repair surgery: a randomized controlled trial. Braz J Anesthesiol. 2023 Sep-Oct;73(5):595-602. doi: 10.1016/j.bjane.2023.05.001. Epub 2023 May 16.

  PMID: 37201747 BACKGROUND

Study Officials

• Oznur Demiroluk, Associate Professor

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant M.D in the Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: January 10, 2024
• Primary Completion: October 17, 2024
• Study Completion: March 3, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)