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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type DRUG

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.

Ultrasound

Intervention Type DEVICE

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

Epinephrine

Intervention Type DRUG

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

acetaminophen

Intervention Type DRUG

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

ibuprofen

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Intervention Type DEVICE

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

acetaminophen

Intervention Type DRUG

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

ibuprofen

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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

Intervention Type DEVICE

Epinephrine

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

Intervention Type DRUG

acetaminophen

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

Intervention Type DRUG

ibuprofen

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

Intervention Type DRUG

Oxycodone

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.

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No