Trial Outcomes & Findings for The Efficacy of Thoracoabdominal Nerve Block With Serratus Intercostal Plane and Rectus Sheath Block in Cholecystectomy (NCT NCT06241794)
NCT ID: NCT06241794
Last Updated: 2025-03-03
Results Overview
Determination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain). The NRS score will be evaluated both at rest and during active movement situations (such as transitioning from a lying to a sitting position). The Numeric Rating Scale (NRS): (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
24 hour
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Group M-TAPA
M-TAPA:
Group M-TAPA: Aseptic conditions are ensured in the area where the block will be performed. Under ultrasound guidance, a linear probe at the sagittal plane and costochondral angle is used to identify the transversus abdominis, internal oblique, and external oblique muscles at the level of the 10th rib. To visualize the lower surface of the rib cartilage in the midline, a sagittal angle is applied with the probe in the direction of the costochondral angle at the edge of the 10th rib. Using a 22-G, 80-100 mm block needle with an in-plane technique, the needle is advanced cranially. The needle tip is directed towards the posterior surface of the 10th rib cartilage, underneath the condyle. Subsequently, 20 ml of 0.25% concentration bupivacaine is injected beneath the condyle. The same procedure will be applied to the opposite side using the same technique.
|
Group Serratus Intercostal Plane Block and Rectus Sheath Block
Group Serratus Intercostal Plane Block and Rectus Sheath Block: Serratus intercostal plane block:The serratus anterior muscle and intercostal muscles are identified at the level of 8th rib along the right mid-axillary line.Using block needle,20 ml of 0.25% Bupivacaine is injected into the interfascial plane between these muscles.The SIPB will be performed only on the right side.
Rectus sheath block:a linear probe is placed in a transverse position just above the umbilicus and slightly lateral to the midline.After visualizing the rectus abdominis muscle, posterior rectus sheath,and the hypoechoic space between them,block needle is advanced in-plane along the subcutaneous tissue.The needle is progressed until reaching the space between the epimysium of the muscle and the posterior rectus sheath, passing horizontally through the anterior rectus sheath of the rectus abdominis muscle.10 ml of 0.25% bupivacaine is injected.Adequate spread will lift the epimysium of rectus abdominis muscle while displacing the posterior fascia and peritoneum downward
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group M-TAPA
n=35 Participants
Group M-TAPA: Aseptic conditions are ensured in the area where the block will be performed. Under ultrasound guidance, a linear probe at the sagittal plane and costochondral angle is used to identify the transversus abdominis, internal oblique, and external oblique muscles at the level of the 10th rib. To visualize the lower surface of the rib cartilage in the midline, a sagittal angle is applied with the probe in the direction of the costochondral angle at the edge of the 10th rib. Using a 22-G, 80-100 mm block needle with an in-plane technique, the needle is advanced cranially. The needle tip is directed towards the posterior surface of the 10th rib cartilage, underneath the condyle. Subsequently, 20 ml of 0.25% concentration bupivacaine is injected beneath the condyle. The same procedure will be applied to the opposite side using the same technique.
|
Group Serratus Intercostal Plane Block and Rectus Sheath Block
n=37 Participants
Group Serratus Intercostal Plane Block and Rectus Sheath Block: Serratus intercostal plane block:The serratus anterior muscle and intercostal muscles are identified at the level of 8th rib along the right mid-axillary line.Using block needle,20 ml of 0.25% Bupivacaine is injected into the interfascial plane between these muscles.The SIPB will be performed only on the right side.
Rectus sheath block:a linear probe is placed in a transverse position just above the umbilicus and slightly lateral to the midline.After visualizing the rectus abdominis muscle, posterior rectus sheath,and the hypoechoic space between them,block needle is advanced in-plane along the subcutaneous tissue.The needle is progressed until reaching the space between the epimysium of the muscle and the posterior rectus sheath, passing horizontally through the anterior rectus sheath of the rectus abdominis muscle.10 ml of 0.25% bupivacaine is injected.Adequate spread will lift the epimysium of rectus abdominis muscle while displacing the posterior fascia and peritoneum downward
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=35 Participants
|
37 Participants
n=37 Participants
|
72 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=35 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=72 Participants
|
|
Age, Continuous
|
44 year
n=35 Participants
|
45 year
n=37 Participants
|
45 year
n=72 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=35 Participants
|
27 Participants
n=37 Participants
|
51 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=35 Participants
|
10 Participants
n=37 Participants
|
21 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
35 participants
n=35 Participants
|
37 participants
n=37 Participants
|
72 participants
n=72 Participants
|
PRIMARY outcome
Timeframe: 24 hourDetermination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain). The NRS score will be evaluated both at rest and during active movement situations (such as transitioning from a lying to a sitting position). The Numeric Rating Scale (NRS): (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain)
Outcome measures
| Measure |
Group M-TAPA
n=35 Participants
Group M-TAPA: Aseptic conditions are ensured in the area where the block will be performed. Under ultrasound guidance, a linear probe at the sagittal plane and costochondral angle is used to identify the transversus abdominis, internal oblique, and external oblique muscles at the level of the 10th rib. To visualize the lower surface of the rib cartilage in the midline, a sagittal angle is applied with the probe in the direction of the costochondral angle at the edge of the 10th rib. Using a 22-G, 80-100 mm block needle with an in-plane technique, the needle is advanced cranially. The needle tip is directed towards the posterior surface of the 10th rib cartilage, underneath the condyle. Subsequently, 20 ml of 0.25% concentration bupivacaine is injected beneath the condyle. The same procedure will be applied to the opposite side using the same technique.
|
Group Serratus Intercostal Plane Block and Rectus Sheath Block
n=37 Participants
Group Serratus Intercostal Plane Block and Rectus Sheath Block: Serratus intercostal plane block:The serratus anterior muscle and intercostal muscles are identified at the level of 8th rib along the right mid-axillary line.Using block needle,20 ml of 0.25% Bupivacaine is injected into the interfascial plane between these muscles.The SIPB will be performed only on the right side.
Rectus sheath block:a linear probe is placed in a transverse position just above the umbilicus and slightly lateral to the midline.After visualizing the rectus abdominis muscle, posterior rectus sheath,and the hypoechoic space between them,block needle is advanced in-plane along the subcutaneous tissue.The needle is progressed until reaching the space between the epimysium of the muscle and the posterior rectus sheath, passing horizontally through the anterior rectus sheath of the rectus abdominis muscle.10 ml of 0.25% bupivacaine is injected.Adequate spread will lift the epimysium of rectus abdominis muscle while displacing the posterior fascia and peritoneum downward
|
|---|---|---|
|
Postoperative Pain Examination
24th hour Active NRS
|
2 score on a scale
Interval 0.0 to 3.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Postoperative Pain Examination
0th hour Rest NRS
|
3 score on a scale
Interval 1.0 to 6.0
|
5 score on a scale
Interval 0.0 to 8.0
|
|
Postoperative Pain Examination
1th hour Rest NRS
|
2 score on a scale
Interval 0.0 to 4.0
|
3 score on a scale
Interval 0.0 to 6.0
|
|
Postoperative Pain Examination
3th hour Rest NRS
|
2 score on a scale
Interval 0.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Postoperative Pain Examination
6th hour Rest NRS
|
1 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 5.0
|
|
Postoperative Pain Examination
12th hour Rest NRS
|
1 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 4.0
|
|
Postoperative Pain Examination
18th hour Rest NRS
|
1 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 5.0
|
|
Postoperative Pain Examination
24th hour Rest NRS
|
1 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 4.0
|
|
Postoperative Pain Examination
0th hour Active NRS
|
4 score on a scale
Interval 2.0 to 8.0
|
6 score on a scale
Interval 1.0 to 9.0
|
|
Postoperative Pain Examination
1th hour Active NRS
|
3 score on a scale
Interval 1.0 to 6.0
|
4 score on a scale
Interval 2.0 to 6.0
|
|
Postoperative Pain Examination
3th hour Active NRS
|
3 score on a scale
Interval 1.0 to 6.0
|
3 score on a scale
Interval 1.0 to 6.0
|
|
Postoperative Pain Examination
6th hour Active NRS
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 6.0
|
|
Postoperative Pain Examination
12th hour Active NRS
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Postoperative Pain Examination
18th hour Active NRS
|
2 score on a scale
Interval 0.0 to 4.0
|
2 score on a scale
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 24 hourTotal 24-hour tramadol consumption of patients in mg.
Outcome measures
| Measure |
Group M-TAPA
n=35 Participants
Group M-TAPA: Aseptic conditions are ensured in the area where the block will be performed. Under ultrasound guidance, a linear probe at the sagittal plane and costochondral angle is used to identify the transversus abdominis, internal oblique, and external oblique muscles at the level of the 10th rib. To visualize the lower surface of the rib cartilage in the midline, a sagittal angle is applied with the probe in the direction of the costochondral angle at the edge of the 10th rib. Using a 22-G, 80-100 mm block needle with an in-plane technique, the needle is advanced cranially. The needle tip is directed towards the posterior surface of the 10th rib cartilage, underneath the condyle. Subsequently, 20 ml of 0.25% concentration bupivacaine is injected beneath the condyle. The same procedure will be applied to the opposite side using the same technique.
|
Group Serratus Intercostal Plane Block and Rectus Sheath Block
n=37 Participants
Group Serratus Intercostal Plane Block and Rectus Sheath Block: Serratus intercostal plane block:The serratus anterior muscle and intercostal muscles are identified at the level of 8th rib along the right mid-axillary line.Using block needle,20 ml of 0.25% Bupivacaine is injected into the interfascial plane between these muscles.The SIPB will be performed only on the right side.
Rectus sheath block:a linear probe is placed in a transverse position just above the umbilicus and slightly lateral to the midline.After visualizing the rectus abdominis muscle, posterior rectus sheath,and the hypoechoic space between them,block needle is advanced in-plane along the subcutaneous tissue.The needle is progressed until reaching the space between the epimysium of the muscle and the posterior rectus sheath, passing horizontally through the anterior rectus sheath of the rectus abdominis muscle.10 ml of 0.25% bupivacaine is injected.Adequate spread will lift the epimysium of rectus abdominis muscle while displacing the posterior fascia and peritoneum downward
|
|---|---|---|
|
Opioid Consumption
|
92.64 mg
Standard Deviation 26.28
|
103.9 mg
Standard Deviation 39.32
|
Adverse Events
Group M-TAPA
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group Serratus Intercostal Plane Block and Rectus Sheath Block
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group M-TAPA
n=35 participants at risk
Group M-TAPA: Aseptic conditions are ensured in the area where the block will be performed. Under ultrasound guidance, a linear probe at the sagittal plane and costochondral angle is used to identify the transversus abdominis, internal oblique, and external oblique muscles at the level of the 10th rib. To visualize the lower surface of the rib cartilage in the midline, a sagittal angle is applied with the probe in the direction of the costochondral angle at the edge of the 10th rib. Using a 22-G, 80-100 mm block needle with an in-plane technique, the needle is advanced cranially. The needle tip is directed towards the posterior surface of the 10th rib cartilage, underneath the condyle. Subsequently, 20 ml of 0.25% concentration bupivacaine is injected beneath the condyle. The same procedure will be applied to the opposite side using the same technique.
|
Group Serratus Intercostal Plane Block and Rectus Sheath Block
n=37 participants at risk
Group Serratus Intercostal Plane Block and Rectus Sheath Block: Serratus intercostal plane block:The serratus anterior muscle and intercostal muscles are identified at the level of 8th rib along the right mid-axillary line.Using block needle,20 ml of 0.25% Bupivacaine is injected into the interfascial plane between these muscles.The SIPB will be performed only on the right side.
Rectus sheath block:a linear probe is placed in a transverse position just above the umbilicus and slightly lateral to the midline.After visualizing the rectus abdominis muscle, posterior rectus sheath,and the hypoechoic space between them,block needle is advanced in-plane along the subcutaneous tissue.The needle is progressed until reaching the space between the epimysium of the muscle and the posterior rectus sheath, passing horizontally through the anterior rectus sheath of the rectus abdominis muscle.10 ml of 0.25% bupivacaine is injected.Adequate spread will lift the epimysium of rectus abdominis muscle while displacing the posterior fascia and peritoneum downward
|
|---|---|---|
|
Gastrointestinal disorders
Nausea or Vomiting
|
17.1%
6/35 • 24 hours
|
18.9%
7/37 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place