Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.

NCT03395912 | Completed DMC

• 1 other identifier: 0151-17-EMC
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief. In the study group before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration. Our hypothesis is that subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of cesarean section will reduce the intensity of post operative pain.

Conditions

Cesarean Section

Keywords

local anesthetics infiltration; cesarean section pain relief

Outcome Measures

Primary Outcomes (1)

• Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.

  Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain.

  up to 24 hours

Secondary Outcomes (8)

• Length of the cesarean section

  up to 24 hours

• Time from surgery to mobility

  up to 48 hours

• Time from surgery to breastfeeding

  up to 4 days

• Need for opioids

  up to 4 days

• Surgical site hematoma

  4 days

Study Arms (2)

Intervention

EXPERIMENTAL

Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.

Drug: Intervention

control

NO INTERVENTION

Abdominal layers will be closed without Infiltration .

Interventions

Intervention DRUG

After closing the fascia above the rectus muscles, and before closing the skin, the subcutaneous layer will be infiltrated on both sides of the incision (top and bottom) by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin.

Also known as: local anesthetic infiltration

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• cesarean section with regional anesthesia
• singleton
• pfannenstiel incision

You may not qualify if:

• cesarean section with general anesthesia
• maternal liver or kidney disease
• allergy to Bupivacaine
• allergy to Adrenalin
• intrauterine fetal death
• major fetal malformations

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek medical center

Afula, Israel

Location

Related Publications (21)

• Karlstrom A, Engstrom-Olofsson R, Norbergh KG, Sjoling M, Hildingsson I. Postoperative pain after cesarean birth affects breastfeeding and infant care. J Obstet Gynecol Neonatal Nurs. 2007 Sep-Oct;36(5):430-40. doi: 10.1111/j.1552-6909.2007.00160.x.

  PMID: 17880313 BACKGROUND

• Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

  PMID: 18818022 BACKGROUND

• Yefet E, Taha H, Salim R, Hasanein J, Carmeli Y, Schwartz N, Nachum Z. Fixed time interval compared with on-demand oral analgesia protocols for post-caesarean pain: a randomised controlled trial. BJOG. 2017 Jun;124(7):1063-1070. doi: 10.1111/1471-0528.14546. Epub 2017 Feb 25.

  PMID: 28236348 BACKGROUND

• Adesope O, Ituk U, Habib AS. Local anaesthetic wound infiltration for postcaesarean section analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Oct;33(10):731-42. doi: 10.1097/EJA.0000000000000462.

  PMID: 27259092 RESULT

• Fredman B, Shapiro A, Zohar E, Feldman E, Shorer S, Rawal N, Jedeikin R. The analgesic efficacy of patient-controlled ropivacaine instillation after Cesarean delivery. Anesth Analg. 2000 Dec;91(6):1436-40. doi: 10.1097/00000539-200012000-00025.

  PMID: 11093995 RESULT

• Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002 Jun;186(6):1188-91. doi: 10.1067/mob.2002.122984.

  PMID: 12066096 RESULT

• Lavand'homme PM, Roelants F, Waterloos H, De Kock MF. Postoperative analgesic effects of continuous wound infiltration with diclofenac after elective cesarean delivery. Anesthesiology. 2007 Jun;106(6):1220-5. doi: 10.1097/01.anes.0000267606.17387.1d.

  PMID: 17525598 RESULT

• Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21. doi: 10.1111/j.1479-828x.1995.tb02156.x.

  PMID: 8717568 RESULT

• Tuncer S, Aysolmaz G, Reisli R, Erol A, Yalcin N, Yosunkaya A. [The effects of the administration of subfacial levobupivacaine infusion with the ON-Q pain pump system on postoperative analgesia and tramadol consumption in cesarean operations]. Agri. 2010 Apr;22(2):73-8. Turkish.

  PMID: 20582749 RESULT

• Zohar E, Shapiro A, Eidinov A, Fishman A, Fredman B. Postcesarean analgesia: the efficacy of bupivacaine wound instillation with and without supplemental diclofenac. J Clin Anesth. 2006 Sep;18(6):415-21. doi: 10.1016/j.jclinane.2006.01.001.

  PMID: 16980157 RESULT

• Jolly C, Jathieres F, Keita H, Jaouen E, Guyot B, Torre A. Cesarean analgesia using levobupivacaine continuous wound infiltration: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:125-30. doi: 10.1016/j.ejogrb.2015.08.023. Epub 2015 Aug 25.

  PMID: 26366789 RESULT

• Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013 Jan;32(1):25-30. doi: 10.1016/j.annfar.2012.10.035. Epub 2012 Dec 21. French.

  PMID: 23260628 RESULT

• Ducarme G, Sillou S, Wernet A, Davitian C, Poujade O, Ceccaldi PF, Bougeois B, Luton D. [Single-shot ropivacaine wound infiltration during cesarean section for postoperative pain relief]. Gynecol Obstet Fertil. 2012 Jan;40(1):10-3. doi: 10.1016/j.gyobfe.2011.07.035. Epub 2011 Oct 22. French.

  PMID: 22024157 RESULT

• Bensghir M, Elwali A, Miller C, Azendour H, Drissi M, Bakkali H, Belyamani L, Atmani M, Drissi Kamili N. [Effects of skin infiltration with ropivacaine 0,75% on postoperative pain after caesarean section]. Gynecol Obstet Fertil. 2008 May;36(5):516-20. doi: 10.1016/j.gyobfe.2008.03.007. Epub 2008 May 7. French.

  PMID: 18467147 RESULT

• Pavy T, Gambling D, Kliffer P, Munro A, Merrick PM, Douglas J. Effect of preoperative skin infiltration with 0.5% bupivacaine on postoperative pain following cesarean section under spinal anesthesia. Int J Obstet Anesth. 1994 Oct;3(4):199-202. doi: 10.1016/0959-289x(94)90068-x.

  PMID: 15636950 RESULT

• Sekhavat L, Behdad S. Preoperative analgesia with local lidocaine for cesarean delivery pain relief. J Matern Fetal Neonatal Med. 2011 Jul;24(7):891-3. doi: 10.3109/14767058.2010.537410. Epub 2011 Jan 10.

  PMID: 21219106 RESULT

• Trotter TN, Hayes-Gregson P, Robinson S, Cole L, Coley S, Fell D. Wound infiltration of local anaesthetic after lower segment caesarean section. Anaesthesia. 1991 May;46(5):404-7. doi: 10.1111/j.1365-2044.1991.tb09558.x.

  PMID: 2035794 RESULT

• Parascandola SA, Ibanez J, Keir G, Anderson J, Plankey M, Flynn D, Cody C, De Marchi L, Margolis M, Blair Marshall M. Liposomal bupivacaine versus bupivacaine/epinephrine after video-assisted thoracoscopic wedge resectiondagger. Interact Cardiovasc Thorac Surg. 2017 Jun 1;24(6):925-930. doi: 10.1093/icvts/ivx044.

  PMID: 28329326 RESULT

• Metaxotos NG, Asplund O, Hayes M. The efficacy of bupivacaine with adrenaline in reducing pain and bleeding associated with breast reduction: a prospective trial. Br J Plast Surg. 1999 Jun;52(4):290-3. doi: 10.1054/bjps.1998.0129.

  PMID: 10624296 RESULT

• Li X, Zhou M, Shi X, Yang H, Li Y, Li J, Yang M, Yuan H. Local anaesthetic wound infiltration used for caesarean section pain relief: a meta-analysis. Int J Clin Exp Med. 2015 Jun 15;8(6):10213-24. eCollection 2015.

  PMID: 26309720 RESULT

• Garmi G, Parasol M, Zafran N, Rudin M, Romano S, Salim R. Efficacy of Single Wound Infiltration With Bupivacaine and Adrenaline During Cesarean Delivery for Reduction of Postoperative Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242203. doi: 10.1001/jamanetworkopen.2022.42203.

  PMID: 36378307 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Gali Garmi, MD

  HaEmek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 10, 2018
• Study Start: January 25, 2018
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2021
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

IL (1)