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Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaginal wound local analgesia after laparoscopic hysterectomy
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring laparoscopic hysterectomy, postoperative pain, local analgesia, vaginal wound

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

The criteria for inclusion were scheduled laparoscopic hysterectomy

Exclusion Criteria:

The exclusion Criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol), language difficulties ( inability to understand and speak Finnish or Swedish)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ropivacaine group

    Control group

    Arm Description

    Vaginal wound local analgesia by 10ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy

    Vaginal wound no local analgesia by 10 ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy

    Outcomes

    Primary Outcome Measures

    Postoperative pain scores
    Visual Analog Score (VAS) for pain. Physicians Global Assessment to measure quality of pain. 10-point VAS score for pain (0-10), 0 indicating no pain and 10 indicating unbearable pain at 1,3,6,12 and 24 h (hour) after surgery (Units on a Scale; 0-10).

    Secondary Outcome Measures

    Complication
    Frequency of complications. Values are given as n (%) and eventual complications are specified.
    Nausea
    Nausea after the procedure: Visual Analog Score (VAS) for nausea. Physicians Global Assessment to measure quality of nausea. 10-point VAS score for nausea (0-10), 0 indicating no nausea and 10 indicating unbearable nausea at 1,3,6,12 and 24 h (hour) after surgery. ( Unit on scale; 0-10).
    Length of hospitalisation
    Length of hospital stay measured from the end of the operation until discharge
    The use of analgesics for postoperative pain
    Postoperative pain defined by the total amount of analgesics used. Amount of used Oxycodone (mg).
    Vomiting
    Vomiting after the procedure: Visual Analog Score (VAS) for vomiting. Physicians Global Assessment to measure quality of vomiting. 10-point VAS score for vomiting (0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting at 1,3,6,12 and 24 h (hour) after surgery. ( Unit on scale; 0-10).

    Full Information

    First Posted
    May 2, 2016
    Last Updated
    May 9, 2016
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02767544
    Brief Title
    Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial
    Official Title
    Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine ( vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative pain and need of oxycodone.
    Detailed Description
    Women assigned to laparoscopic hysterectomy were randomly divided into two groups as regard surgery: a ropivacaine group (RG) (n=41) and a control group (CG) (n=40). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    laparoscopic hysterectomy, postoperative pain, local analgesia, vaginal wound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ropivacaine group
    Arm Type
    Experimental
    Arm Description
    Vaginal wound local analgesia by 10ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Vaginal wound no local analgesia by 10 ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Vaginal wound local analgesia after laparoscopic hysterectomy
    Primary Outcome Measure Information:
    Title
    Postoperative pain scores
    Description
    Visual Analog Score (VAS) for pain. Physicians Global Assessment to measure quality of pain. 10-point VAS score for pain (0-10), 0 indicating no pain and 10 indicating unbearable pain at 1,3,6,12 and 24 h (hour) after surgery (Units on a Scale; 0-10).
    Time Frame
    Change in 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Complication
    Description
    Frequency of complications. Values are given as n (%) and eventual complications are specified.
    Time Frame
    Up to one week
    Title
    Nausea
    Description
    Nausea after the procedure: Visual Analog Score (VAS) for nausea. Physicians Global Assessment to measure quality of nausea. 10-point VAS score for nausea (0-10), 0 indicating no nausea and 10 indicating unbearable nausea at 1,3,6,12 and 24 h (hour) after surgery. ( Unit on scale; 0-10).
    Time Frame
    Change in 24 hours after surgery.
    Title
    Length of hospitalisation
    Description
    Length of hospital stay measured from the end of the operation until discharge
    Time Frame
    Up to one week
    Title
    The use of analgesics for postoperative pain
    Description
    Postoperative pain defined by the total amount of analgesics used. Amount of used Oxycodone (mg).
    Time Frame
    Change in 24 hours after surgery
    Title
    Vomiting
    Description
    Vomiting after the procedure: Visual Analog Score (VAS) for vomiting. Physicians Global Assessment to measure quality of vomiting. 10-point VAS score for vomiting (0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting at 1,3,6,12 and 24 h (hour) after surgery. ( Unit on scale; 0-10).
    Time Frame
    Change in 24 hours after surgery.

    10. Eligibility

    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The criteria for inclusion were scheduled laparoscopic hysterectomy Exclusion Criteria: The exclusion Criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol), language difficulties ( inability to understand and speak Finnish or Swedish)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Päivi I Pakarinen, MD PhD
    Organizational Affiliation
    Helsinki University Central Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17507163
    Citation
    Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.
    Results Reference
    background
    PubMed Identifier
    19592483
    Citation
    Brummer TH, Jalkanen J, Fraser J, Heikkinen AM, Kauko M, Makinen J, Puistola U, Sjoberg J, Tomas E, Harkki P. FINHYST 2006--national prospective 1-year survey of 5,279 hysterectomies. Hum Reprod. 2009 Oct;24(10):2515-22. doi: 10.1093/humrep/dep229. Epub 2009 Jul 10.
    Results Reference
    background
    PubMed Identifier
    24576202
    Citation
    Hristovska AM, Kristensen BB, Rasmussen MA, Rasmussen YH, Elving LB, Nielsen CV, Kehlet H. Effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy: a randomized, placebo-controlled trial. Acta Obstet Gynecol Scand. 2014 Mar;93(3):233-8. doi: 10.1111/aogs.12319.
    Results Reference
    background
    PubMed Identifier
    22209702
    Citation
    Beaussier M, Bouaziz H, Aubrun F, Belbachir A, Binhas M, Bloc S, Fuzier R, Jochum D, Nouette-Gaulain K, Paqueron X; membres du comite douleur-ALR de Sfar. [Wound infiltration with local anesthetics for postoperative analgesia. Results of a national survey about its practice in France]. Ann Fr Anesth Reanim. 2012 Feb;31(2):120-5. doi: 10.1016/j.annfar.2011.10.017. Epub 2011 Dec 29. French.
    Results Reference
    background
    PubMed Identifier
    10741813
    Citation
    Kato J, Ogawa S, Katz J, Nagai H, Kashiwazaki M, Saeki H, Suzuki H. Effects of presurgical local infiltration of bupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecologic examinations: a possible preemptive analgesic effect. Clin J Pain. 2000 Mar;16(1):12-7. doi: 10.1097/00002508-200003000-00003.
    Results Reference
    background
    PubMed Identifier
    20979101
    Citation
    Kahokehr A, Sammour T, Srinivasa S, Hill AG. Systematic review and meta-analysis of intraperitoneal local anaesthetic for pain reduction after laparoscopic gastric procedures. Br J Surg. 2011 Jan;98(1):29-36. doi: 10.1002/bjs.7293.
    Results Reference
    background

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    Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial

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