Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420337
• Other study ID #: ESOGU 3
• Status: Completed
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 15, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Complications

Intervention

Procedure:
• Group intramuscular
Group I will be applied 20 ml of % 0.25 bupivacain internal oblique and transversus abdominis muscle and 0.1 mg/kg morphine intramuscular. The blocks will be administered under general anesthesia in supine position by the same anesthesiologist.
• 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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Hospital	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 hours
Secondary	Systemic effects	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.	24 hours