NCT06342076

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable postoperative-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

March 21, 2024

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • visuel analog scale

    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.

    24 hours postoperatively

Secondary Outcomes (1)

  • amount of opioid used

    24 hours postoperatively

Study Arms (2)

Group1: Subcostal transversus abdominis plane block(STAPB)

EXPERIMENTAL

Subcostal transversus abdominis plane block(STAPB)

Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane blockProcedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block

Group 2: Rectus sheat block(RSB)

EXPERIMENTAL

Rectus sheat block(RSB)

Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane blockProcedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block

Interventions

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.

Group 2: Rectus sheat block(RSB)Group1: Subcostal transversus abdominis plane block(STAPB)

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.

Group 2: Rectus sheat block(RSB)Group1: Subcostal transversus abdominis plane block(STAPB)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • ASA II-III

You may not qualify if:

  • 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

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 (5)

  • Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.

  • Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

  • Yorukoglu HU, Sahin T, Oge Kula A. Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Caesarean Delivery: A Randomised Controlled Trial. Turk J Anaesthesiol Reanim. 2023 Feb;51(1):43-48. doi: 10.5152/TJAR.2023.22724.

  • Soliz JM, Lipski I, Hancher-Hodges S, Speer BB, Popat K. Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. Anesth Pain Med. 2017 Oct 20;7(5):e12923. doi: 10.5812/aapm.12923. eCollection 2017 Oct.

  • Abdelsalam K, Mohamdin OW. Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study. Saudi J Anaesth. 2016 Jan-Mar;10(1):25-8. doi: 10.4103/1658-354X.169470.

MeSH Terms

Conditions

Pain, PostoperativePostoperative ComplicationsAgnosia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Prospective randomize study
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective randomize study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 2, 2024

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations