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Status unknownNCT02767544Updated May 10, 2016

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

An interventional study of Vaginal wound local analgesia after laparoscopic hysterectomy in Postoperative Pain, sponsored by Helsinki University Central Hospital. Status unknown. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-10.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
30 Years to 80 Years
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Study 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.

Read the 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.

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Conditions studied

  • Postoperative Pain

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Keywords

  • laparoscopic hysterectomy
  • postoperative pain
  • local analgesia
  • vaginal wound
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 81 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Accepts healthy volunteers
No

Inclusion criteria

The criteria for inclusion were scheduled laparoscopic hysterectomy

Exclusion criteria

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)

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    ropivacaine group

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

    Procedure: Vaginal wound local analgesia after laparoscopic hysterectomy

  • No intervention
    Control group

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

Interventions

  • ProcedureVaginal wound local analgesia after laparoscopic hysterectomy
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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Change in 24 hours after surgery

Secondary outcomes

  1. Complication

    Frequency of complications. Values are given as n (%) and eventual complications are specified.

    Time frame: Up to one week

  2. 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).

    Time frame: Change in 24 hours after surgery.

  3. Length of hospitalisation

    Length of hospital stay measured from the end of the operation until discharge

    Time frame: Up to one week

  4. The use of analgesics for postoperative pain

    Postoperative pain defined by the total amount of analgesics used. Amount of used Oxycodone (mg).

    Time frame: Change in 24 hours after surgery

  5. 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).

    Time frame: Change in 24 hours after surgery.

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 17507163 ↗
  • 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. PubMed 19592483 ↗
  • 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. PubMed 24576202 ↗
  • 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. PubMed 22209702 ↗
  • 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. PubMed 10741813 ↗
  • 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. PubMed 20979101 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02767544
Lead sponsor
Helsinki University Central Hospital
Responsible party
Päivi Päkarinen (MD PhD, Helsinki University Central Hospital) — Principal investigator
First posted
May 10, 2016
Start date
Nov 2014
Primary completion
Oct 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
May 10, 2016

Study contacts

Päivi I Pakarinen, MD PhD
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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