Effectiveness of Thoracoabdominal Nerve Block (M-TAPA) on Postoperative Pain Relief in Laparoscopic Hysterectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorIstinye University
About this trial
This study aims to investigate the effectiveness of a specific regional anesthesia technique, the Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA), on reducing pain after laparoscopic hysterectomy surgery. Hysterectomy is a common major surgical procedure, and managing postoperative pain is crucial for patient comfort and faster recovery.
Participants will be randomly assigned to one of two groups:
The M-TAPA Group: Patients will receive the nerve block using a local anesthetic (bupivacaine) before the surgery begins.
The Control Group: Patients will receive standard postoperative pain management without the nerve block.
The primary goal is to determine if the M-TAPA block reduces the total amount of opioid (morphine) used by patients in the first 24 hours after surgery. The researchers will also evaluate pain scores (NRS), the time until the first request for additional pain medication, patient satisfaction, and any side effects like nausea or vomiting
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 70 years
ASA (American Society of Anesthesiologists) physical status I, II, or III
Scheduled for elective laparoscopic hysterectomy
Voluntary participation with signed informed consent
Disqualifiers
Hepatic or renal disease.
Coagulation disorders.
Uncontrolled cardiovascular or respiratory diseases.
Psychiatric disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA)
Procedure/SurgeryUnder ultrasound guidance, a 22-gauge peripheral block needle is inserted at the costochondral angle (9th-10th ribs). After confirming the position, 20 ml of 0.25% bupivacaine is injected bilaterally into the lower part of the chondrium.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: M-TAPA GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Morphine consumption
Total amount of morphine (mg) used via Patient-Controlled Analgesia (PCA)
Time frame
First 24 hours postoperativelySecondary outcomes
1
Postoperative Pain Scores (NRS)
Numerical Rating Scale (0=no pain, 10=worst pain)
Time frame
Baseline (Hour 0), 1, 2, 4, 6, 12, and 24 hours postoperatively2
Rescue analgesic drug consumption
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Time frame
Within the first 24 hours postoperatively3
Incidence of postoperative nausea and vomiting
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
Time frame
Within the first 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov