Acute Pain Clinical Trial
Official title:
Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy
NCT number | NCT02519023 |
Other study ID # | 7152222222 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | June 2017 |
Verified date | January 2019 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | June 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
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. — View Citation
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. — View 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Opioid Use for Pain Control | total opioid used from time 0 after surgery through 72 hours after surgery was complete. | 72 hours | |
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. | 0-72 hours post-procedure | |
Secondary | Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents | 0-24 post-procedure | ||
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. | 72 hours post-procedure | |
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. | 72 hours post-procedure | |
Secondary | Number of Participants With Nausea and Vomiting | 72 hours post-procedure | ||
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. | an expected average of 120 mins | |
Secondary | Number of Patients Admitted Post Operatively | 72 hours post-procedure | ||
Secondary | Opioid Used From 24-48 Hours Post Surgery | opioids in mg of morphine equivalents used from 24-48 hours after surgery | 24-48 hours after the end of surgery | |
Secondary | Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents | opioid use from time 48-72 hours in mg morphine equivalents | 48-72 hours after end of surgery | |
Secondary | Patient Satisfaction With Pain Management | number of patients who answered yes to if they were satisfied with their pain management | at 72 hours after surgery | |
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. | 0-24 hours after surgery | |
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. | 24-48 hours after surgery | |
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. | 48-72 hours after surgery |
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