Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

NCT02712151 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: IRB-P00022058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy is associated with considerable postoperative pain and surgeon-administered local anesthetic infiltration is the standard practice for achieving post-operative analgesia. However, recent studies have shown that pediatric patients continue to experience significant pain during the first 24 hours. The investigators plan to conduct a prospective, double-blinded, randomized study where patients will be designated into either a test group receiving an ultrasound-guided transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and surgical team will both be blinded as well as the research personal in the postoperative period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing laparoscopic cholecystectomy will be included. The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single shot transversus abdominis plane and rectus sheath blocks, are superior to local wound infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain related behavior and facilitating functional recovery.

Conditions

Pain, Postoperative

Keywords

transversus abdominal plane block

Outcome Measures

Primary Outcomes (1)

• cumulative opioid consumption (both intravenous and enteral) during the perioperative period

  24 hours

Secondary Outcomes (5)

• post-operative patient-reported pain scores upon arrival to the post-operative care unit and inpatient unit

  every eight hours thereafter on the hospital floor for total of 24 hours postoperatively

• post-operative episodes of opioid-related side effects, such as nausea, vomiting, constipation, urinary retention, and pruritis

  24 hours

• time to first liquid and/or solid PO intake

  24 hours

• time to mobilization out of bed

  24 hours

• overall patient functional recovery evidenced by validated patient surveys

  24 hours

Study Arms (2)

Abdominal Wall Block with Ropivacaine 0.2%

ACTIVE COMPARATOR

Patients will receive bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.

Procedure: Abdominal Wall Block; Procedure: Surgical infiltration; Drug: Sterile saline; Drug: Ropivacaine 0.2%; Device: Ultrasound

Surgical Infiltration with Ropivacaine 0.5%

ACTIVE COMPARATOR

Patients will receive surgical infiltration of local anesthetic into the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine, divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline will be used for the nerve blocks.

Procedure: Abdominal Wall Block; Procedure: Surgical infiltration; Drug: Sterile saline; Device: Ultrasound; Drug: Ropivacaine 0.5%

Interventions

Abdominal Wall Block PROCEDURE

bilateral TAP and RS blocks.

Abdominal Wall Block with Ropivacaine 0.2%; Surgical Infiltration with Ropivacaine 0.5%

Surgical infiltration PROCEDURE

distributed between the 4 laparoscopic port sites.

Abdominal Wall Block with Ropivacaine 0.2%; Surgical Infiltration with Ropivacaine 0.5%

Sterile saline DRUG

Placebo injection

Abdominal Wall Block with Ropivacaine 0.2%; Surgical Infiltration with Ropivacaine 0.5%

Ropivacaine 0.2% DRUG

Ropivacaine 0.2% 1.0 ml/kg total in divided doses for bilateral TAP and RS blocks.

Abdominal Wall Block with Ropivacaine 0.2%

Ultrasound DEVICE

For nerve localization

Abdominal Wall Block with Ropivacaine 0.2%; Surgical Infiltration with Ropivacaine 0.5%

Ropivacaine 0.5% DRUG

Ropivacaine 0.5% 0.4 ml/kg total in divided doses distributed between the 4 laparoscopic port sites

Surgical Infiltration with Ropivacaine 0.5%

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient age 5-17 years old at time of surgery
• ASA status 1-2
• Parent is able to provide informed consent and patient's \> age 7 able to give assent
• Patients scheduled for laparoscopic cholecystectomy
• Surgery will involve and be limited to laparoscopic cholecystectomy
• Admission status: 24-hour admission to hospital

You may not qualify if:

• Non-English speaking parents/patient.
• All emergency laparoscopic cholecystectomies or conversion to an open procedure
• Patients who will remain intubated or require ICU care postoperatively
• Significant liver or renal disease
• Coagulopathy
• Underlying neurocognitive disorder or developmental delay affecting ability to convey feelings of pain to medical staff
• Diagnosis of chronic pain syndrome
• Active infection over nerve block sites
• History of allergy to local anesthetic agents or non-steroidal anti-inflammatory drugs (NSAIDS)
• Known alcohol or substance abuse within the past 6 months
• Daily Opioid use
• ASA class 3 or higher

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.

  PMID: 8867249 RESULT

• Joshi GP, Beck DE, Emerson RH, Halaszynski TM, Jahr JS, Lipman AG, Nihira MA, Sheth KR, Simpson MH, Sinatra RS. Defining new directions for more effective management of surgical pain in the United States: highlights of the inaugural Surgical Pain Congress. Am Surg. 2014 Mar;80(3):219-28.

  PMID: 24666860 RESULT

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 RESULT

• Joshi GP, Kehlet H. Procedure-specific pain management: the road to improve postsurgical pain management? Anesthesiology. 2013 Apr;118(4):780-2. doi: 10.1097/ALN.0b013e31828866e1. No abstract available.

  PMID: 23388191 RESULT

• Kluivers KB, Riphagen I, Vierhout ME, Brolmann HA, de Vet HC. Systematic review on recovery specific quality-of-life instruments. Surgery. 2008 Feb;143(2):206-15. doi: 10.1016/j.surg.2007.08.017. Epub 2007 Dec 21.

  PMID: 18242337 RESULT

• Kleinbeck SV. Self-reported at-home postoperative recovery. Res Nurs Health. 2000 Dec;23(6):461-72. doi: 10.1002/1098-240X(200012)23:63.0.CO;2-S.

  PMID: 11130605 RESULT

• Chambers CT, Reid GJ, McGrath PJ, Finley GA. Development and preliminary validation of a postoperative pain measure for parents. Pain. 1996 Dec;68(2-3):307-13. doi: 10.1016/s0304-3959(96)03209-5.

  PMID: 9121819 RESULT

• von Baeyer CL, Chambers CT, Eakins DM. Development of a 10-item short form of the parents' postoperative pain measure: the PPPM-SF. J Pain. 2011 Mar;12(3):401-6. doi: 10.1016/j.jpain.2010.10.002. Epub 2010 Dec 17.

  PMID: 21167790 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Karen Boretsky, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karen Boretsky

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 18, 2016
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)