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Cesarean SectionNCT03395912

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

A study testing Intervention in people with Cesarean Section, run by HaEmek Medical Center, Israel at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Cesarean Section
What is being tested?
Intervention
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
1 siteIsrael
Study dates
25 Jan 2018to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • cesarean section with regional anesthesia
  • singleton
  • pfannenstiel incision

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • HaEmek medical center

    Afula

Other trials in Israel

About this study

Official title: Efficacy of a Single-shot Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section in Reducing Postoperative Pain. A Randomized Prospective Controlled Trial

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.

Read the detailed description

Cesarean section is one of the most common procedures in the world. There is an advantage in preventing pain after cesarean section, as opposed to treating pain that has already started. The infiltration of surgical wounds by local anesthetics is accepted as an effective method for preventing pain after various operations. In this study women who are admitted for a cesarean section will be randomly allocated into 2 groups. In the study group after the closure of the fascia above the rectus muscles, and 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.

Being tested
Intervention
Keywords
local anesthetics infiltration, cesarean section pain relief

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionDrug

    Also called local anesthetic infiltration

    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.

Study groups in NCT03395912
Study groupRoleWhat they receive
InterventionExperimentalInfiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.
Receives: Drug: Intervention
controlNo interventionAbdominal layers will be closed without Infiltration .

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 24 hours

Secondary outcomes (8)

  1. Length of the cesarean section

    Time from first incision to the end of incision closure

    Measured: up to 24 hours

  2. Time from surgery to mobility

    Time from the end of surgery to mobility

    Measured: up to 48 hours

  3. Time from surgery to breastfeeding

    Time from the end of surgery to breastfeeding

    Measured: up to 4 days

  4. Need for opioids

    Type and dosage of opioids needed

    Measured: up to 4 days

  5. Surgical site hematoma

    Post operative surgical site hematoma

    Measured: 4 days

  6. surgical site infection

    Post operative surgical site infection

    Measured: up to 42 days

  7. questionnaire

    Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction.

    Measured: up to 4 days

  8. Length of stay from surgery to discharge

    Length of stay from surgery to discharge

    Measured: up to 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start25 Jan 2018
  3. Primary completion30 May 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395912
Sponsor's protocol ID
0151-17-EMC
Status last verified
Oct 2022
First submitted
21 Dec 2017
Last updated
19 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: undecided

Publications

  • 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.

    PubMed 17880313

  • 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.

    PubMed 18818022

  • 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.

    PubMed 28236348

  • 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.

    PubMed 27259092

  • 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.

    PubMed 11093995

  • 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.

    PubMed 12066096

  • 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.

    PubMed 17525598

  • 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.

    PubMed 8717568

  • 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.

    PubMed 20582749

  • 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.

    PubMed 16980157

  • 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.

    PubMed 26366789

  • 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.

    PubMed 23260628

  • 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.

    PubMed 22024157

  • 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.

    PubMed 18467147

  • 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.

    PubMed 15636950

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Cesarean Section, run by HaEmek Medical Center, Israel at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department. (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03395912, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.

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