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TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy

Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02519023
Enrollment
87
Registered
2015-08-10
Start date
2016-07-31
Completion date
2017-06-30
Last updated
2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Brief summary

Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.

Detailed description

This is a double blinded randomized study. All patients will receive one form of local anesthetic pain relief either from TAP or infiltration. Patients will be randomized to one of two study arms in a double-blinded, placebo controlled study. All patients will receive a TAP infiltration and all patients will receive infiltration into the incision. In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site. In the second arm the bilateral TAP infiltration will consist of 30 mL of normal saline per side. In the same arm the surgeon infiltration will consist of 10 mL of 0.25% bupivacaine per port site. The surgeon infiltration will consist of 5 ml of 0.25% bupivacaine prior to incision and 5 ml of 0.25% bupivacaine prior to closure at each port site. A TAP infiltration is an injection of local anesthetic under the covering of the transversus abdominis muscle layer which provides effective post operative analgesia.2-5 This layer is found using an ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound the investigators can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is infiltrated into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and facial layers of the abdomen. This is currently standard of care at our institution and will be performed within one hour of surgical incision. The injection will consist of 10 mL of 0.25% bupivacaine with epinephrine followed by 20 mL of liposomal bupivacaine saline mixture or 10 ml of saline followed by 20 ml of saline and then repeated on the contralateral side. Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions. Investigational Drug Service (IDS) pharmacy will be charged with the blinding of medications vs. saline for these procedures. Following the procedure, all individuals will receive scheduled acetaminophen (1 gram every 6 hours), scheduled ibuprofen (800 mg every 8 hours), and PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.

Interventions

DRUGLiposomal Bupivacaine

In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.

DRUGBupivacaine

Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.

DEVICEUltrasound

An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane

DRUGEpinephrine

TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.

DRUGacetaminophen

all individuals will receive scheduled acetaminophen (1 gram every 6 hours),

DRUGibuprofen

all individuals will receive scheduled ibuprofen (800 mg every 8 hours)

DRUGOxycodone

all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA physical status I-III * Females \>/=18-years of age * Scheduled for laparoscopic/robot-assisted hysterectomy.

Exclusion criteria

* Contraindication to surgical infiltration or regional blockade * History of long term opioid intake (greater than 3 weeks prior to surgery) or chronic pain disorder * Inability to understand the informed consent and demands of the study * Surgery scheduled to start after 1700

Design outcomes

Primary

MeasureTime frameDescription
Total Opioid Use for Pain Control72 hourstotal opioid used from time 0 after surgery through 72 hours after surgery was complete.

Secondary

MeasureTime frameDescription
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents0-24 post-procedure
Quality of Recovery 15 (QoR15) Score72 hours post-procedureThe quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome.
Maximal Pain Score of Patient From Time 0-24 Hours After Surgery0-24 hours after surgerythe maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Overall Benefit of Analgesia Score (OBAS)72 hours post-procedureThe overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome.
Number of Participants With Nausea and Vomiting72 hours post-procedure
Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)0-72 hours post-procedurethe Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30.
Number of Patients Admitted Post Operatively72 hours post-procedure
Opioid Used From 24-48 Hours Post Surgery24-48 hours after the end of surgeryopioids in mg of morphine equivalents used from 24-48 hours after surgery
Patient Satisfaction With Pain Managementat 72 hours after surgerynumber of patients who answered yes to if they were satisfied with their pain management
Maximal Pain Score for Patient From Time 24-48 Hours After Surgery24-48 hours after surgerythe maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Maximal Pain Score Patient Felt From 48-72 Hours After Surgery48-72 hours after surgerythe maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Length of Time in Phase 1 and Phase 2 of Recoveryan expected average of 120 minstime from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge.

Countries

United States

Participant flow

Participants by arm

ArmCount
TAP-Block With Liposomal Bupivacaine
TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site. Liposomal Bupivacaine: In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.
31
Surgical Infiltration With Bupivacaine
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions. Bupivacaine: Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions. Ultrasound: An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane
31
Total62

Baseline characteristics

CharacteristicSurgical Infiltration With BupivacaineTotalTAP-Block With Liposomal Bupivacaine
Age, Continuous62 years59 years58 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
31 participants62 participants31 participants
Sex: Female, Male
Female
31 Participants62 Participants31 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 31
other
Total, other adverse events
10 / 3116 / 31
serious
Total, serious adverse events
0 / 310 / 31

Outcome results

Primary

Total Opioid Use for Pain Control

total opioid used from time 0 after surgery through 72 hours after surgery was complete.

Time frame: 72 hours

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineTotal Opioid Use for Pain Control20.8 mg Morphine equivalents
Surgical Infiltration With BupivacaineTotal Opioid Use for Pain Control25.0 mg Morphine equivalents
Secondary

Length of Time in Phase 1 and Phase 2 of Recovery

time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge.

Time frame: an expected average of 120 mins

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineLength of Time in Phase 1 and Phase 2 of Recovery3.3 hours
Surgical Infiltration With BupivacaineLength of Time in Phase 1 and Phase 2 of Recovery3.1 hours
Secondary

Maximal Pain Score for Patient From Time 24-48 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.

Time frame: 24-48 hours after surgery

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineMaximal Pain Score for Patient From Time 24-48 Hours After Surgery3 units on a scale
Surgical Infiltration With BupivacaineMaximal Pain Score for Patient From Time 24-48 Hours After Surgery4 units on a scale
Secondary

Maximal Pain Score of Patient From Time 0-24 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.

Time frame: 0-24 hours after surgery

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineMaximal Pain Score of Patient From Time 0-24 Hours After Surgery3 units on a scale
Surgical Infiltration With BupivacaineMaximal Pain Score of Patient From Time 0-24 Hours After Surgery5 units on a scale
Secondary

Maximal Pain Score Patient Felt From 48-72 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.

Time frame: 48-72 hours after surgery

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineMaximal Pain Score Patient Felt From 48-72 Hours After Surgery2 units on a scale
Surgical Infiltration With BupivacaineMaximal Pain Score Patient Felt From 48-72 Hours After Surgery3 units on a scale
Secondary

Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)

the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30.

Time frame: 0-72 hours post-procedure

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineMaximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)8 scores on a scale
Surgical Infiltration With BupivacaineMaximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)13 scores on a scale
Secondary

Number of Participants With Nausea and Vomiting

Time frame: 72 hours post-procedure

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP-Block With Liposomal BupivacaineNumber of Participants With Nausea and Vomiting10 Participants
Surgical Infiltration With BupivacaineNumber of Participants With Nausea and Vomiting16 Participants
Secondary

Number of Patients Admitted Post Operatively

Time frame: 72 hours post-procedure

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP-Block With Liposomal BupivacaineNumber of Patients Admitted Post Operatively11 Participants
Surgical Infiltration With BupivacaineNumber of Patients Admitted Post Operatively16 Participants
Secondary

Opioid Used From 24-48 Hours Post Surgery

opioids in mg of morphine equivalents used from 24-48 hours after surgery

Time frame: 24-48 hours after the end of surgery

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineOpioid Used From 24-48 Hours Post Surgery0 mg of morphine equivalents
Surgical Infiltration With BupivacaineOpioid Used From 24-48 Hours Post Surgery.5 mg of morphine equivalents
Secondary

Overall Benefit of Analgesia Score (OBAS)

The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome.

Time frame: 72 hours post-procedure

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineOverall Benefit of Analgesia Score (OBAS)2 scores on a scale
Surgical Infiltration With BupivacaineOverall Benefit of Analgesia Score (OBAS)3 scores on a scale
Secondary

Patient Satisfaction With Pain Management

number of patients who answered yes to if they were satisfied with their pain management

Time frame: at 72 hours after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP-Block With Liposomal BupivacainePatient Satisfaction With Pain Management30 Participants
Surgical Infiltration With BupivacainePatient Satisfaction With Pain Management24 Participants
Secondary

Quality of Recovery 15 (QoR15) Score

The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome.

Time frame: 72 hours post-procedure

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineQuality of Recovery 15 (QoR15) Score126 scores on a scale
Surgical Infiltration With BupivacaineQuality of Recovery 15 (QoR15) Score115 scores on a scale
Secondary

Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

Time frame: 0-24 post-procedure

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineTotal Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents7.5 mg of morphine equivalents
Surgical Infiltration With BupivacaineTotal Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents22.5 mg of morphine equivalents
Secondary

Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

opioid use from time 48-72 hours in mg morphine equivalents

Time frame: 48-72 hours after end of surgery

ArmMeasureValue (MEDIAN)
TAP-Block With Liposomal BupivacaineTotal Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents0 mg morphine equivalents
Surgical Infiltration With BupivacaineTotal Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents5 mg morphine equivalents

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026