TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | July 2016 |
| End Date: | June 2017 |
Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy
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.
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.
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.
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.
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
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