Laparascopic TAP and Hysterectomy Trial #2

NCT03711981 | Completed

• 1 other identifier: 16-027
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

More than 600,000 hysterectomies are performed in the United States each year, making it the most common non-obstetric major surgery performed on women1. Estimates suggest that at least 30% of hysterectomies are performed laparoscopically or robotically with an increasing trend toward minimally invasive approaches2. While a minimally invasive approach certainly provides improved recovery, patients still experience substantial pain and most require opiate medications for pain control. Incorporating a multimodal approach to postoperative pain management through the use of field nerve blocks is potentially an ideal way to enhance recovery and minimize the need for narcotic pain medications. Over the past decade, the use of Transversus Abdominis Plane (TAP) blocks as an adjunct for postoperative pain management has gained in popularity. First described in 2001 by Dr. Rafi of Limerick3, Ireland, TAP blocks are now typically performed by an anesthesiologist with the use of ultrasound guidance. The transversus abdominis plane is the neurovascular plane between the aponeurosis of the internal oblique and transversus abdominis muscles. Herein lie the afferent nociceptor nerve endings of T7-L1. Injection of a 20-30cc volume of anesthetic into this plane causes a sensory nerve block to the ipsilateral antero-abdominal wall from the costal margin to the symphysis pubis4. Clinical trials have documented the validity of using TAP blocks for both open and laparoscopic procedures and verified their use for postsurgical pain relief. Studies have demonstrated that TAP blocks for both open and laparoscopic hysterectomies are safe and efficacious5, 6. In 2011, De Oliveira et al. demonstrated improved quality of recovery for women undergoing preoperative ultrasound guided TAP infiltration with ropivacaine at the time of laparoscopic hysterectomy7.

Conditions

Anesthesia

Keywords

laparascopic, surgery, anesthesia

Outcome Measures

Primary Outcomes (1)

• Overall Benefit of Anesthesia Score (OBAS)

  Change in resting pain, vomiting, itching, sweating, freezing, dizziness, satisfaction Likert 0-10 0=not at all, 10- very much

  Post operative day 7

Secondary Outcomes (2)

• OBAS Questionnaire

  Post operative day 1

• OBAS Questionnaire

  Post operative day 2

Study Arms (2)

TAP block of 10cc Liposomal bupivacaine

ACTIVE COMPARATOR

Patients in this arm of the study would receive a bilateral Laparoscopic Assisted TAP block with 10cc Liposomal bupivacaine, 10cc 0.25% bupivacaine and 10cc normal saline each bilaterally at the beginning of their surgery.

Procedure: TAP Block

Routine pre-incisional injections at trocar incision sites

NO INTERVENTION

The patients in the control arm of the study would receive routine pre-incisional injections at the trocar incision sites using a total of 20cc 0.25% bupivacaine.

Interventions

TAP Block PROCEDURE

TAP block of 10cc Liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Gynecologic procedure applicable to females only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult women
• undergoing laparoscopic robotic assisted laparoscopic hysterectomy with or without removal of adnexa

You may not qualify if:

• \< 18
• Not undergoing laparoscopic hysterectomy

Sponsors & Collaborators

• University of Tennessee: lead

Related Publications (7)

• De Oliveira GS Jr, Milad MP, Fitzgerald P, Rahmani R, McCarthy RJ. Transversus abdominis plane infiltration and quality of recovery after laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1230-1237. doi: 10.1097/AOG.0b013e318236f67f.

  PMID: 22105251 BACKGROUND

• Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.

  PMID: 16738152 RESULT

• Committee opinion no. 628: robotic surgery in gynecology. Obstet Gynecol. 2015 Mar;125(3):760-767. doi: 10.1097/01.AOG.0000461761.47981.07.

  PMID: 25730256 RESULT

• Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

  PMID: 11576144 RESULT

• Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.

  PMID: 22312327 RESULT

• Bhattacharjee S, Ray M, Ghose T, Maitra S, Layek A. Analgesic efficacy of transversus abdominis plane block in providing effective perioperative analgesia in patients undergoing total abdominal hysterectomy: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):391-6. doi: 10.4103/0970-9185.137274.

  PMID: 25190950 RESULT

• Atim A, Bilgin F, Kilickaya O, Purtuloglu T, Alanbay I, Orhan ME, Kurt E. The efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing hysterectomy. Anaesth Intensive Care. 2011 Jul;39(4):630-4. doi: 10.1177/0310057X1103900415.

  PMID: 21823381 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which type of injection they have received for pain control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients in one arm of the study would receive a bilateral Laparoscopic Assisted TAP block with 10cc Liposomal bupivacaine, 10cc 0.25% bupivacaine and 10cc normal saline each bilaterally at the beginning of their surgery. The patients in the control arm of the study would receive pre-incisional injections at the trocar incision sites using a total of 20cc 0.25% bupivacaine.

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: October 19, 2018
• Study Start: January 27, 2016
• Primary Completion: April 15, 2017
• Study Completion: December 15, 2017
• Last Updated: October 19, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share