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

• ClinicalTrials.gov Identifier: NCT02519023
• Recruitment Status: Completed
• First Posted: August 10, 2015
• Results First Posted: December 5, 2018
• Last Update Posted: February 8, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Pain	Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Device: Ultrasound; Drug: Epinephrine; Drug: acetaminophen; Drug: ibuprofen; Drug: Oxycodone	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy
• Study Start Date: July 2016
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Other Name: Exparel; Device: 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; Drug: Epinephrine; TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.; Drug: acetaminophen; all individuals will receive scheduled acetaminophen (1 gram every 6 hours),; Drug: ibuprofen; all individuals will receive scheduled ibuprofen (800 mg every 8 hours); 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.
Active Comparator: 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.	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.; Device: 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; Drug: acetaminophen; all individuals will receive scheduled acetaminophen (1 gram every 6 hours),; Drug: ibuprofen; all individuals will receive scheduled ibuprofen (800 mg every 8 hours); 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.

Outcome Measures

Primary Outcome Measures :

1. Total Opioid Use for Pain Control [ Time Frame: 72 hours ]
   total opioid used from time 0 after surgery through 72 hours after surgery was complete.

Secondary Outcome Measures :

1. Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10) [ Time Frame: 0-72 hours post-procedure ]
   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.
2. Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents [ Time Frame: 0-24 post-procedure ]
3. Quality of Recovery 15 (QoR15) Score [ Time Frame: 72 hours post-procedure ]
   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.
4. Overall Benefit of Analgesia Score (OBAS) [ Time Frame: 72 hours post-procedure ]
   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.
5. Number of Participants With Nausea and Vomiting [ Time Frame: 72 hours post-procedure ]
6. Length of Time in Phase 1 and Phase 2 of Recovery [ Time Frame: an expected average of 120 mins ]
   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.
7. Number of Patients Admitted Post Operatively [ Time Frame: 72 hours post-procedure ]
8. Opioid Used From 24-48 Hours Post Surgery [ Time Frame: 24-48 hours after the end of surgery ]
   opioids in mg of morphine equivalents used from 24-48 hours after surgery
9. Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents [ Time Frame: 48-72 hours after end of surgery ]
   opioid use from time 48-72 hours in mg morphine equivalents
10. Patient Satisfaction With Pain Management [ Time Frame: at 72 hours after surgery ]
    number of patients who answered yes to if they were satisfied with their pain management
11. Maximal Pain Score of Patient From Time 0-24 Hours After Surgery [ Time Frame: 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.
12. Maximal Pain Score for Patient From Time 24-48 Hours After Surgery [ Time Frame: 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.
13. Maximal Pain Score Patient Felt From 48-72 Hours After Surgery [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Melissa Geller, MD; University of Minnesota

  Study Documents (Full-Text)

Documents provided by University of Minnesota:

Study Protocol  [PDF] July 25, 2015

No Statistical Analysis Plan (SAP) exists for this study.

More Information

Publications:

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.

Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Møller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.

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.

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. Review.

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02519023
• Other Study ID Numbers: 7152222222
• First Posted: August 10, 2015
• Results First Posted: December 5, 2018
• Last Update Posted: February 8, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Acute Pain; Pain; Neurologic Manifestations; Acetaminophen; Ibuprofen; Epinephrine; Oxycodone; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents