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Completed

NCT Number: NCT05420337

Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University Hospital

Eskişehir, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group ıntramuscular

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.

Other names: Fascial plane block and ıntramuscular morphine at lower abdominal surgery

Group TAP

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.

Other names: Fascial plane block with morphine at lower abdominal surgery

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

    Time frame: 24 hours

    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.

Secondary outcomes

  1. Systemic effects

    Time frame: 24 hours

    Hemodynamic changes, nausea-vomiting (1-none, 2-mild, 3-moderate, 4-severe), itching (1-none, 2-mild, 3-moderate, 4-severe) and ramsay sedation scale systemic effects will be evaluated.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block; Is it Systemic or Regional Effect?

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2022
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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