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

NCT ID: NCT02767544

Last Updated: 2016-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ropivacaine group

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

Group Type EXPERIMENTAL

Vaginal wound local analgesia after laparoscopic hysterectomy

Intervention Type PROCEDURE

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vaginal wound local analgesia after laparoscopic hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

The criteria for inclusion were scheduled laparoscopic hysterectomy
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Päivi Päkarinen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Päivi I Pakarinen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

References

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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.

Reference Type BACKGROUND
PMID: 17507163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19592483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24576202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22209702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10741813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20979101 (View on PubMed)

Other Identifiers

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98/13/03/03/2014/2

Identifier Type: -

Identifier Source: org_study_id

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