Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block

Sponsor

Eskisehir Osmangazi University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05420337

Collaborator

(none)

Enrollment

Location

Arms

16.2

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Postoperative Complications	Procedure: Group ıntramuscular Procedure: Group TAP	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Triple (Participant, 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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 24, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Intramuscular Transversus Abdominis Plane Block will administer with 20 ml of % 0.25 bupivacaine and 0.1 mg/kg morphine intramuscular	Procedure: 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. Other Names: Fascial plane block and ıntramuscular morphine at lower abdominal surgery
Active Comparator: Group TAP Transversus Abdominis Plane Block will administer with 20 ml of % 0.25 bupivacaine and 0.1 mg/kg morphine	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. Other Names: Fascial plane block with morphine at lower abdominal surgery

Arm

Intervention/Treatment

Active Comparator: Group Intramuscular

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

Procedure: 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.

Other Names:

Fascial plane block and ıntramuscular morphine at lower abdominal surgery

Active Comparator: Group TAP

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

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.

Other Names:

Fascial plane block with morphine at lower abdominal surgery

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.