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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06382376
Other study ID # 2024-60
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date March 1, 2024

Study information

Verified date April 2024
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries. The key question(s) it aims to answer are: [Is intrathecal morphine more effective in postoperative analgesia?] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use.


Description:

Our study was designed retrospectively. The investigators evaluated analgesia methods in patients who underwent laparoscopic or open surgery due to gynecological cancer between June 2023 and December 2023. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block on postoperative analgesia and opioid use. Group 1: Intrathecal morphine administered group Group 2: Four quadrant transversus abdominis plane block applied group


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date March 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 18 years - Patients who have undergone gynecological cancer surgery Exclusion Criteria: - <18 years - Those with missing data

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group
Intrathecal morphine administered group and Four quadrant transversus abdominis plane block applied group

Locations

Country Name City State
Turkey Basaksehir Çam and Sakura City Hospital Istanbul Basaksehir

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Black KA, Nelson G, Goucher N, Foley J, Pin S, Chong M, Ghosh S, Bisch SP. Effect of transversus abdominis plane block on postoperative outcomes in gynecologic oncology patients managed on an Enhanced Recovery After Surgery pathway. Gynecol Oncol. 2023 No — View Citation

Meylan N, Elia N, Lysakowski C, Tramer MR. Benefit and risk of intrathecal morphine without local anaesthetic in patients undergoing major surgery: meta-analysis of randomized trials. Br J Anaesth. 2009 Feb;102(2):156-67. doi: 10.1093/bja/aen368. — View Citation

Niraj G, Kelkar A, Hart E, Kaushik V, Fleet D, Jameson J. Four quadrant transversus abdominis plane block and continuous transversus abdominis plane analgesia: a 3-year prospective audit in 124 patients. J Clin Anesth. 2015 Nov;27(7):579-84. doi: 10.1016/ — View Citation

Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative numerical rating scale Our primary aim was to evaluate numerical rating scale at 24 hours postoperatively. numerical rating scale(NRS) was used to assess postoperative pain. NRS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable. 24 hours postoperatively
Secondary postoperative opioid use Our secondary aim was to evaluate opioid demand and consumption amounts in the postoperative 24 hours. 24 hours postoperatively
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