Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

Abdominal Cancer Clinical Trial

Official title:

Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06384677
• Other study ID #: 03.03.2023/371
• Status: Completed
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.

Description:

The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patient > 17 years old
• ASA score 1-3
• undergoing major intra-abdominal surgery

Exclusion Criteria:

• ASA IV patients
• patients with known neurological or psychiatric disorders
• patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
• patients with long-term drug (opioid) or alcohol dependence
• patients with BMI>30
• patients with intellectual disability
• patients who developed massive bleeding and coagulopathy

Related Conditions & MeSH terms

• Abdomen Disease
• Abdominal Cancer

Intervention

Other:
• M-Tapa Block
M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Hoyme U, Baumueller A, Madsen PO. Antibiotics excretion in canine vaginal and urethral secretions. Invest Urol. 1978 Jul;16(1):35-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	The postoperative opioid consumption	Postoperative 48 hours
Secondary	NRS Scores	Numeric Rating Scale score (rating from 1 to 10. 1:no pain to 10: worst pain ever)	postoperative 48 hours
Secondary	the need for rescue analgesia	if NRS>4: apply rescue analgesia: the total count of rescue analgesia need	postoperative 48 hours
Secondary	side effects	nausea- vomiting	postoperative 48 hours