NCT06382376

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 20, 2024

Last Update Submit

April 24, 2024

Conditions

Keywords

gynecological cancer surgeryperiferal blockneuraxial block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • postoperative opioid use

    24 hours postoperatively

Study Arms (2)

Group 1: Intrathecal morphine administered group

Group 1: Intrathecal morphine administered group

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

Group 2: Four quadrant transversus abdominis plane block applied group

Group 2: Four quadrant transversus abdominis plane block applied group

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

Interventions

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

Also known as: Group 1: Intrathecal morphine administered group, Group 2: Four quadrant transversus abdominis plane block applied group
Group 1: Intrathecal morphine administered groupGroup 2: Four quadrant transversus abdominis plane block applied group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between June 1, 2023 and December 1, 2023, 71 patients over the age of 18 who underwent surgery for ASA II and III gynecological cancer, to whom we applied intrathecal morphine or four-quadrant transversus abdominis plane block (TAPB) from peripheral nerve blocks for postoperative analgesia, were included in the study.

You may qualify if:

  • years
  • Patients who have undergone gynecological cancer surgery

You may not qualify if:

  • \<18 years
  • Those with missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

Location

Related 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 Nov;178:1-7. doi: 10.1016/j.ygyno.2023.09.003. Epub 2023 Sep 18.

  • 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/j.jclinane.2015.07.005. Epub 2015 Aug 28.

  • 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 2022 Jul 6.

  • 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.

Study Officials

  • Duygu Akyol

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2024

First Posted

April 24, 2024

Study Start

June 1, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations