NCT05420337

Brief Summary

Postoperative pain is a condition that increases morbidity and mortality. Therefore, multimodal analgesia techniques with fascial plan blocks are frequently used.TAP block provides analgesia in the anterior abdominal wall by applying local anesthetic to the fascia between the internal oblique and transversus abdominis muscle. Opioids can be added to local anesthetics to increase the quality and duration of analgesia. The investigators aim is comparasion of TAP block with bupivacaine added morphine and TAP block with bupivacaine plus intramuscular morphine effects on postoperative pain score, total opioid consumption and systemic effects in lower abdominal surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 24, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

June 10, 2022

Last Update Submit

April 1, 2023

Conditions

Keywords

postoperative paintransversus abdominis plane blockmorphine

Outcome Measures

Primary Outcomes (1)

  • Comparasion of TAP block with bupivacaine added morphine and TAP block with bupivacaine plus intramuscular morphine effects on postoperative pain score and total opioid consumption in lower abdominal surgery

    Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain)) Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours.

    24 hours

Secondary Outcomes (1)

  • Systemic effects

    24 hours

Study Arms (2)

Group Intramuscular

ACTIVE COMPARATOR

Transversus Abdominis Plane Block will administer with 20 ml of % 0.25 bupivacaine and 0.1 mg/kg morphine intramuscular

Procedure: Group ıntramuscular

Group TAP

ACTIVE COMPARATOR

Transversus Abdominis Plane Block will administer with 20 ml of % 0.25 bupivacaine and 0.1 mg/kg morphine

Procedure: Group TAP

Interventions

Group I will be applied 20 ml of % 0.25 bupivacain internal oblique and transversus abdominis muscle and 0.1 mg/kg morphine ıntramuscular. The blocks will be administered under general anesthesia in supine position by the same anesthesiologist.

Also known as: Fascial plane block and ıntramuscular morphine at lower abdominal surgery
Group Intramuscular
Group TAPPROCEDURE

Group T will be applied 20 ml of % 0.25 bupivacain and 0.1 mg/kg morphine internal oblique and transversus abdominis muscle. The blocks will be administered under general anesthesia in supine position by the same anesthesiologist.

Also known as: Fascial plane block with morphine at lower abdominal surgery
Group TAP

Eligibility Criteria

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

You may qualify if:

  • ASA I-II
  • Lower abdominal gynecological surgery

You may not qualify if:

  • Patients with a known allergy to the study drugs,
  • Significant cardiac, respiratory, renal or hepatic diseases,
  • Bleeding diathesis
  • Those with psychiatric illnesses that would interfere with perception and assessment of pain were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University Hospital

Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (6)

  • El Sherif FA, Mohamed SA, Kamal SM. The effect of morphine added to bupivacaine in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia following lower abdominal cancer surgery, a randomized controlled study. J Clin Anesth. 2017 Jun;39:4-9. doi: 10.1016/j.jclinane.2017.03.009. Epub 2017 Mar 10.

    PMID: 28494906BACKGROUND
  • Chen Q, Liu X, Zhong X, Yang B. Addition of dexmedetomidine or fentanyl to ropivacaine for transversus abdominis plane block: evaluation of effect on postoperative pain and quality of recovery in gynecological surgery. J Pain Res. 2018 Nov 16;11:2897-2903. doi: 10.2147/JPR.S178516. eCollection 2018.

    PMID: 30532583BACKGROUND
  • Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

    PMID: 29226150BACKGROUND
  • Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.

    PMID: 23811424BACKGROUND
  • Sehgal N, Smith HS, Manchikanti L. Peripherally acting opioids and clinical implications for pain control. Pain Physician. 2011 May-Jun;14(3):249-58.

    PMID: 21587328BACKGROUND
  • Onay M, Kaya O, Telli E, Bilir A, Gulec MS. Are the Analgesic Effects of Morphine Added to Transversus Abdominis Plane Block Systemic or Regional? A Randomized Clinical Trial. Pain Res Manag. 2025 Mar 12;2025:9187270. doi: 10.1155/prm/9187270. eCollection 2025.

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Meryem Onay

    Eskisehir Osmangazi University Faculty Of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In the postoperative period, the effectiveness and safety of the block will be evaluated by another researcher (blind) who does not know which group the patient is in.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Group I: TAP block with bupivacain and morphine intramuscular will be applied at the end of the operation. Patients will receive paracetamol 1gr 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period. Group T: TAP block with bupivacain and morphine will be applied at the end of the operation. Patients will receive paracetamol 1gr 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor-Anesthesiologist

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

August 24, 2022

Primary Completion

March 12, 2023

Study Completion

March 15, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations