Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block

Not Applicable

Completed

• Conditions: Pain, Postoperative; Postoperative Complications

• Registration Number: NCT05420337
• Lead Sponsor: Eskisehir Osmangazi University

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.

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-15
• Study Start: 2022-08-24
• Status Verified: 2023-03
• Primary Completion: 2023-03-12
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-04-01
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Systemic effects	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.

Trial Locations

Locations (1)

Eskisehir Osmangazi University Hospital; 🇹🇷 Eskisehir, Turkey