Trial Outcomes & Findings for ESP Block VS TAP in Laparoscopic Hysterectomy (NCT NCT04003987)

NCT ID: NCT04003987

Last Updated: 2022-07-05

Results Overview

Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 78 participants
• Primary outcome timeframe: 1 hour after surgery
• Results posted on: 2022-07-05

Participant Flow

Participant milestones

Measure	ESP Block For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Overall Study STARTED	39	39
Overall Study COMPLETED	39	39
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	Total n=78 Participants Total of all reporting groups	ESP Block n=39 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Age, Categorical <=18 years	78 Participants n=78 Participants	39 Participants n=39 Participants	39 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=78 Participants	0 Participants n=39 Participants	0 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=78 Participants	0 Participants n=39 Participants	0 Participants n=39 Participants
Age, Continuous	44.9 years STANDARD_DEVIATION 1.3 • n=78 Participants	47.1 years STANDARD_DEVIATION 1.9 • n=39 Participants	42.7 years STANDARD_DEVIATION 1.8 • n=39 Participants
Sex: Female, Male Female	78 Participants n=78 Participants	39 Participants n=39 Participants	39 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=78 Participants	0 Participants n=39 Participants	0 Participants n=39 Participants
Race and Ethnicity Not Collected	0 Participants Race and Ethnicity were not collected from any participant.	—	—
Region of Enrollment United States	78 participants n=78 Participants	39 participants n=39 Participants	39 participants n=39 Participants

PRIMARY outcome

Timeframe: 1 hour after surgery

Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)

Outcome measures

Measure	ESP Block n=39 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.	2.8 score on a scale Standard Error 0.5	3 score on a scale Standard Error 0.4

PRIMARY outcome

Timeframe: 24 hours after surgery

Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10)

Outcome measures

Measure	ESP Block n=39 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.	3 score on a scale Standard Error 0.4	2.8 score on a scale Standard Error 0.4

PRIMARY outcome

Timeframe: 48 hours after surgery

Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10)

Outcome measures

Measure	ESP Block n=39 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.	2.1 score on a scale Standard Error 0.4	2 score on a scale Standard Error 0.3

PRIMARY outcome

Timeframe: 1 hour after surgery

Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10)

Outcome measures

Measure	ESP Block n=39 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.	3 score on a scale Standard Error 0.5	3.5 score on a scale Standard Error 0.4

PRIMARY outcome

Timeframe: 24 hours after surgery

Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10)

Outcome measures

Measure	ESP Block n=39 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.	4.3 score on a scale Standard Error 0.4	4.1 score on a scale Standard Error 0.4

PRIMARY outcome

Timeframe: 48 hours after surgery

Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10)

Outcome measures

Measure	ESP Block n=39 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.	3.4 score on a scale Standard Error 0.4	3.2 score on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: 1 hour after surgery

Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)

Outcome measures

Measure	ESP Block n=38 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Sedation Score at 1 Hour Sleep	15 Participants	15 Participants
Patient Sedation Score at 1 Hour Awake	23 Participants	24 Participants

SECONDARY outcome

Timeframe: 24 hours after surgery

Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep)

Outcome measures

Measure	ESP Block n=36 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Sedation Score at 24 Hours Sleep	2 Participants	1 Participants
Patient Sedation Score at 24 Hours Awake	34 Participants	38 Participants

SECONDARY outcome

Timeframe: 48 hours after surgery

Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)

Outcome measures

Measure	ESP Block n=35 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Sedation Score at 48 Hours Sleep	0 Participants	1 Participants
Patient Sedation Score at 48 Hours Awake	35 Participants	38 Participants

SECONDARY outcome

Timeframe: 1 hour after surgery

Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)

Outcome measures

Measure	ESP Block n=38 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Nausea Score at 1 Hour No	33 Participants	33 Participants
Patient Nausea Score at 1 Hour Yes	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 24 hour after surgery

Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)

Outcome measures

Measure	ESP Block n=36 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Nausea Score at 24 Hour Yes	11 Participants	7 Participants
Patient Nausea Score at 24 Hour No	25 Participants	32 Participants

SECONDARY outcome

Timeframe: 48 hour after surgery

Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)

Outcome measures

Measure	ESP Block n=35 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Nausea Score at 48 Hour Yes	2 Participants	7 Participants
Patient Nausea Score at 48 Hour No	33 Participants	32 Participants

SECONDARY outcome

Timeframe: 24 hours after surgery

patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)

Outcome measures

Measure	ESP Block n=36 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Satisfaction Score at 24 Hours	3.7 score on a scale Standard Error 0.1	3.6 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: 48 hours after surgery

patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)

Outcome measures

Measure	ESP Block n=36 Participants For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml	TAP Block n=39 Participants For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml
Patient Satisfaction Score at 48 Hours	3.7 score on a scale Standard Error 0.1	3.7 score on a scale Standard Error 0.1

Adverse Events

ESP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yar Yeap

Indiana University School of Medicine

Phone: (317) 274-0275

Email: yyeap@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place