Clinical trial NCT02519023: TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy
Official title: Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Opioid Use for Pain Control
timeFrame: 72 hours
Secondary outcomes:
measure: Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
timeFrame: 0-72 hours post-procedure
measure: Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
timeFrame: 0-24 post-procedure
measure: Quality of Recovery 15 (QoR15) Score
timeFrame: 72 hours post-procedure
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: 72 hours post-procedure
measure: Number of Participants With Nausea and Vomiting
timeFrame: 72 hours post-procedure
measure: Length of Time in Phase 1 and Phase 2 of Recovery
timeFrame: an expected average of 120 mins
measure: Number of Patients Admitted Post Operatively
timeFrame: 72 hours post-procedure
measure: Opioid Used From 24-48 Hours Post Surgery
timeFrame: 24-48 hours after the end of surgery
measure: Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
timeFrame: 48-72 hours after end of surgery
measure: Patient Satisfaction With Pain Management
timeFrame: at 72 hours after surgery
measure: Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
timeFrame: 0-24 hours after surgery
measure: Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
timeFrame: 24-48 hours after surgery
measure: Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
timeFrame: 48-72 hours after surgery
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Melissa Geller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.
citation: Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.
citation: Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
citation: Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
citation: Singh M, Chin KJ, Chan V. Ultrasound-guided transversus abdominis plane (TAP) block: a useful adjunct in the management of postoperative respiratory failure. J Clin Anesth. 2011 Jun;23(4):303-6. doi: 10.1016/j.jclinane.2010.05.012.