Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block

NCT ID: NCT05420337

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-24

Study Completion Date

2023-03-15

Brief Summary

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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

Detailed Description

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At the end of the operation, patients will be randomly divided into 2 groups as Group I (Intramuskuler) and Group T (TAP block). The blocks will be administered under general anesthesia in supine position by same anesthesiologist. Group I (Intramuskuler) will be applied 20 ml of %0.25 bupivacaine between the internal oblique and transversus abdominis muscle and 0.1 mg/kg (ideal body weight) morphine to be performed intramuscular. Group T will be applied 20 ml of %0.25 bupivacaine and 0.1 mg/kg morphine (ideal body weight) between the internal oblique and transversus abdominis muscle. At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, morphine consumption, nausea-vomiting score, itching, ramsey sedation scale, length of hospital stay and postoperative complications will be recorded.

Conditions

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Pain, Postoperative Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Group Intramuscular

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

Group Type ACTIVE_COMPARATOR

Group ıntramuscular

Intervention Type PROCEDURE

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.

Group TAP

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

Group Type ACTIVE_COMPARATOR

Group TAP

Intervention Type PROCEDURE

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.

Interventions

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Group ıntramuscular

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.

Intervention Type PROCEDURE

Group TAP

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.

Intervention Type PROCEDURE

Other Intervention Names

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Fascial plane block and ıntramuscular morphine at lower abdominal surgery Fascial plane block with morphine at lower abdominal surgery

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* Lower abdominal gynecological surgery

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Meryem Onay

Specialist Doctor-Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meryem Onay

Role: PRINCIPAL_INVESTIGATOR

Eskisehir Osmangazi University Faculty Of Medicine

Locations

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Eskisehir Osmangazi University Hospital

Eskişehir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28494906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30532583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29226150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23811424 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21587328 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40109499 (View on PubMed)

Other Identifiers

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ESOGU 3

Identifier Type: -

Identifier Source: org_study_id

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