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Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05420337
Enrollment
52
Registered
2022-06-15
Start date
2022-08-24
Completion date
2023-03-15
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Postoperative Complications

Keywords

postoperative pain, transversus abdominis plane block, morphine

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

Detailed description

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.

Interventions

PROCEDUREGroup 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.

PROCEDUREGroup 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.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 surgery24 hoursVisual 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

MeasureTime frameDescription
Systemic effects24 hoursHemodynamic 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026