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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02767544
• Other study ID #: 98/13/03/03/2014/2
• Status: Active, not recruiting
• Phase: N/A
• First received: May 2, 2016
• Last updated: May 9, 2016
• Start date: November 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Vaginal wound local analgesia after laparoscopic hysterectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

References & Publications (6)

Beaussier M, Bouaziz H, Aubrun F, Belbachir A, Binhas M, Bloc S, Fuzier R, Jochum D, Nouette-Gaulain K, Paqueron X; membres du comité 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. — View Citation

Brummer TH, Jalkanen J, Fraser J, Heikkinen AM, Kauko M, Mäkinen J, Puistola U, Sjöberg J, Tomás E, Härkki 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. — View 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. — View Citation

Jokela R, Ahonen J, Tallgren M, Haanpää 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. Epub 2007 May 15. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change in 24 hours after surgery	No
Secondary	Complication	Frequency of complications. Values are given as n (%) and eventual complications are specified.	Up to one week	No
Secondary	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).	Change in 24 hours after surgery.	No
Secondary	Length of hospitalisation	Length of hospital stay measured from the end of the operation until discharge	Up to one week	No
Secondary	The use of analgesics for postoperative pain	Postoperative pain defined by the total amount of analgesics used. Amount of used Oxycodone (mg).	Change in 24 hours after surgery	No
Secondary	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).	Change in 24 hours after surgery.	No