NCT03017638

Brief Summary

Pain after abdominal surgery can be extensive. Pain control is an important component of patient comfort and participation in rehabilitation. Multimodal analgesia methods have shown to reduce postoperative pain, and have been addressed to be a crucial part of the Enhanced Recovery after Surgery (ERAS) protocols. Quadratus lumborum block (QLB) is a posterior abdominal wall block which analgesic efficacy has been shown for abdominal surgeries, and also for different laparoscopic procedures, such as ovarian surgery. The aim of this study is to assess QLB's analgesic efficacy for laparoscopic colectomy surgeries, using serial pain score assessments and overall opioid consumption; its effect on patient satisfaction; and its effect on the development of postoperative respiratory complications. This study is a prospective clinical trial assessing the effect of application of QLB as a regional analgesic technique for primary laparoscopic colectomy, in comparison to a historical retrospective cohort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2018

Completed
Last Updated

May 15, 2018

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

January 10, 2017

Last Update Submit

May 9, 2018

Conditions

Block

Outcome Measures

Primary Outcomes (3)

  • Verbal analogue scale (VAS)

    patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) elicited during the patient's post operative recovery unit (PACU)

    24 Hours

  • Verbal analogue scale (VAS)

    patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) on postoperative day 1

    24 hours

  • Verbal analogue scale (VAS)

    patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) on postoperative day 2

    48 hours

Secondary Outcomes (10)

  • Total opioid consumption in PACU

    24 hours

  • Total opioid consumption on postoperative day 1.

    24 hours

  • Total opioid consumption postoperative day 2

    48 hours

  • Total opioid consumption at four weeks postoperatively

    4 weeks

  • Length of hospital stay

    1 week

  • +5 more secondary outcomes

Study Arms (2)

Patients receiving QLB and questionaires

Patients undergoing primary laparoscopic colectomy patients under general anesthesia with an additional Quadratus lumborum block (QLB ) will be asked to fill out a questionnaires detailing: numeric verbal analogue scores (VAS) and quality of recovery score(QoR) preoperatively, 24 hours and 48 hours and four weeks after surgery. Additional data will be collected: ASA physical status, demographics, intra- and post operative opiate(expressed as morphine equivalent in mg/kg) and non opiate consumption in order to assess the analgesic efficacy of QLB for primary laparoscopic colectomy. QLB will be performed as per standard routine regimens, in the operating room after induction of general anesthesia and prior to surgery.

Other: Questionaire

Historical control

The control subjects' data will be assessed reviewing patient records. Data will include: * Maximal PACU VAS pain score (per nursing charts) * Overall POD 24 hours and 48 hours and 4 weeks opioid consumption (overall morphine mg/kg equivalent dose) * POD 24 and 48 hours and 4 weeks Respiratory complications

Interventions

QuestionaireOTHER

Patients undergoing primary laparoscopic colectomy patients under general anesthesia with an additional Quadratus lumborum block (QLB ) will be asked to fill out a questionnaires detailing: numeric verbal analogue scores (VAS) and quality of recovery score(QoR) preoperatively, 24 hours, 48 hour and four weeks after surgery. Additional data will be collected: ASA physical status, demographics, intra- and post operative opiate(expressed as morphine equivalent in mg/kg) and non opiate consumption in order to assess the analgesic efficacy of QLB for primary laparoscopic colectomy. QLB will be performed as per standard routine regimens, in the operating room after induction of general anesthesia and prior to surgery.

Patients receiving QLB and questionaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include adults older than 18 years who are American Society of Anesthesiologists (ASA) Physical Status (PS) Classes 1-3. Inclusion criteria are patients undergoing primary laparoscop colectomy under general anesthesia with QLB.

You may not qualify if:

  • Previous abdominal surgery
  • Allergy to local anesthetics or to systemic opioids
  • Contraindication to regional anesthesia technique, such as local infection or coagulopathy, or patients receiving anticoagulation therapy with smaller specifications than listed in professional guidelines.
  • Contraindication to the Quadratus lumborum block such as defects or interferences in the abdominal wall obstructing anatomical structure visibility.
  • Requirements of more than 30 mg morphine equivalent daily prior to surgery
  • ASA IV or greater
  • Psychiatric or cognitive disorders
  • Incarceration
  • Renal insufficiency with Cr \> 2.0
  • Hepatic failure
  • Pregnancy
  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petach Tikvah, Israel

Location

Related Publications (10)

  • Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.

    PMID: 18627367RESULT

  • Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

    PMID: 22221014RESULT

  • O'Donnell BD, Iohom G. Regional anesthesia techniques for ambulatory orthopedic surgery. Curr Opin Anaesthesiol. 2008 Dec;21(6):723-8. doi: 10.1097/aco.0b013e328314b665.

    PMID: 19009687RESULT

  • Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.

    PMID: 23302898RESULT

  • Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.

    PMID: 20571832RESULT

  • Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.

    PMID: 21821506RESULT

  • Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

    PMID: 9895071RESULT

  • Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

    PMID: 10740540RESULT

  • Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

    PMID: 2805470RESULT

  • Melvin JS, Stryker LS, Sierra RJ. Tranexamic Acid in Hip and Knee Arthroplasty. J Am Acad Orthop Surg. 2015 Dec;23(12):732-40. doi: 10.5435/JAAOS-D-14-00223. Epub 2015 Oct 22.

    PMID: 26493971RESULT

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Shia Fein, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 11, 2017

Study Start

February 27, 2017

Primary Completion

January 14, 2018

Study Completion

January 14, 2018

Last Updated

May 15, 2018

Record last verified: 2017-01

Locations

IL(1)