The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section.

Post Operative Pain Clinical Trial

— TRON  

Official title:

The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section. A Prospective, Observational and Non-inferiority Study Against Epidural Analgesia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879536
• Other study ID #: TRON
• Status: Recruiting
• Start date: May 23, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2023
• Source: Hospital Universitario La Fe
• Contact: Jose Daniel Jimenez Santana, Resident
• Phone: +34629826331
• Email: jimenez_josedanielsan[@]gva.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It will be a prospective observational cohort study. The investigators will compare post-cesarean section recovery in patients receiving intravenous infusion of tramadol-ondansetron versus epidural catheter with infusion of local anesthetics.

Description:

The primary outcome is to assess the non-inferiority in terms of post-cesarean section recovery of the intravenous perfusion of tramadol + ondansetron compared to the perfusion of local anesthetics through an epidural catheter. This will be a prospective observational cohort study, with a total N of 312 patients who underwent a cesarean section. 156 who maintain the epidural catheter as the main measure of analgesia for 24 h, and 156 who receive an infusion of tramadol-ondansetron from the end of the cesarean section and for the following 24 h. The following data will be collected at 24 and 48 hours: need for unscheduled pharmacological reinforcement, adverse effects, QoR (Quality of Recovery) score 15, ObsQor-10 (Obstetric Quality of Recovery) score, and Visual Analogue Pain Scale (VAS) every 4 hours for 48 hours. The incidence of chronic pain 90 days after cesarean section will be assessed using the Numerical Pain Rating Scale (NRS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Woman over 18 years old undergoing caesarean section
• She agrees to participate voluntarily.
• She is already receiving any of the analgesic strategies studied.

Exclusion Criteria:

• Receiving an analgesic medication other than the one mentioned as "routine multimodal analgesia" (either as regular medication or for acute post-surgical pain)
• Medical history that determines the baseline data of the scales and data that we collect ( pain or previous disabilities; addiction to drugs, alcohol or drugs; another disease that worsens the quality of life)
• Medical history that conditions the pharmacological effect (allergy, intolerance or atypical reaction to any of the drugs involved in its treatment or possible cross-reactions )
• Contraindication for neuraxial techniques (patient refusal, difficulty in understanding or communication, localized infection, increased intracranial pressure, or other medical criteria)
• Two or more previous caesarean sections
• Difficulty in understanding or communication

Related Conditions & MeSH terms

• Cesarean Section
• Ondansetron
• Pain, Postoperative
• Post Operative Pain
• Postoperative Recovery
• Quality of Recovery

Intervention

Drug:
• Tramadol-ondansetron continuous infusion
Analgesia strategy determined by routine use according to protocols, without investigator intervention.
• Ropivacaine via epidural catheter
Analgesia strategy determined by routine use according to protocols, without investigator intervention.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (28)

Boney O, Moonesinghe SR, Myles PS, Grocott MPW; StEP-COMPAC group. Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia. Br J Anaesth. 2022 Jan;128(1):174-185. doi: 10.1016/j.bja.2021.09.027. Epub 2021 Nov 2. — View Citation

Borges NC, de Deus JM, Guimaraes RA, Conde DM, Bachion MM, de Moura LA, Pereira LV. The incidence of chronic pain following Cesarean section and associated risk factors: A cohort of women followed up for three months. PLoS One. 2020 Sep 4;15(9):e0238634. doi: 10.1371/journal.pone.0238634. eCollection 2020. — View Citation

Chi X, Li M, Mei W, Liao M. Comparison of patient-controlled intravenous analgesia with sufentanil versus tramadol in post-cesarean section pain management and lactation after general anesthesia - a prospective, randomized, double-blind, controlled study. J Pain Res. 2017 Jul 3;10:1521-1527. doi: 10.2147/JPR.S137799. eCollection 2017. — View Citation

Ciechanowicz S, Howle R, Heppolette C, Nakhjavani B, Carvalho B, Sultan P. Evaluation of the Obstetric Quality-of-Recovery score (ObsQoR-11) following non-elective caesarean delivery. Int J Obstet Anesth. 2019 Aug;39:51-59. doi: 10.1016/j.ijoa.2019.01.010. Epub 2019 Feb 2. — View Citation

Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31. — View Citation

Delfino E, Netto R, Zanon D. Pain control after cesarean delivery: a new proposal for a continuous locoregional technique. Int J Obstet Anesth. 2021 Nov;48:103196. doi: 10.1016/j.ijoa.2021.103196. Epub 2021 Jun 23. No abstract available. — View Citation

Duan G, Bao X, Yang G, Peng J, Wu Z, Zhao P, Zuo Z, Li H. Patient-controlled intravenous tramadol versus patient-controlled intravenous hydromorphone for analgesia after secondary cesarean delivery: a randomized controlled trial to compare analgesic, anti-anxiety and anti-depression effects. J Pain Res. 2018 Dec 18;12:49-59. doi: 10.2147/JPR.S184782. eCollection 2019. — View Citation

Jayaraj A, Balachander H, Kuppusamy SK, Arusamy S, Rai Y, Siddiqui N. Comparison of meperidine, tramadol and fentanyl for post-spinal shivering prevention during cesarean delivery: A double-blind randomized controlled trial. J Obstet Gynaecol Res. 2019 Nov;45(11):2202-2208. doi: 10.1111/jog.14106. Epub 2019 Sep 4. — View Citation

Johansen A, Schirmer H, Nielsen CS, Stubhaug A. Persistent post-surgical pain and signs of nerve injury: the Tromso Study. Acta Anaesthesiol Scand. 2016 Mar;60(3):380-92. doi: 10.1111/aas.12653. Epub 2015 Nov 5. — View Citation

Kozanhan B, Yildiz M, Polat A, Gunenc O, Tutar SM, Iyisoy MS, Kulhan NG, Sultan P. Development and Validation of a Turkish Version of Obstetric Quality of Recovery-10. Turk J Anaesthesiol Reanim. 2022 Oct;50(5):366-372. doi: 10.5152/TJAR.2022.21441. — View Citation

Lavand'homme P. Postpartum chronic pain. Minerva Anestesiol. 2019 Mar;85(3):320-324. doi: 10.23736/S0375-9393.18.13060-4. Epub 2018 Oct 30. — View Citation

Ma J, Martin R, Chan B, Gofeld M, Geary MP, Laffey JG, Abdallah FW. Using Activity Trackers to Quantify Postpartum Ambulation: A Prospective Observational Study of Ambulation after Regional Anesthesia and Analgesia Interventions. Anesthesiology. 2018 Mar;128(3):598-608. doi: 10.1097/ALN.0000000000001979. — View Citation

Mathias LAST, Carlos RV, Siaulys MM, Gabriades P, Guo N, Domingue B, O'Carroll J, Carvalho B, Sultan P. Development and validation of a Portuguese version of Obstetric Quality of Recovery-10 (ObsQoR-10-Portuguese). Anaesth Crit Care Pain Med. 2022 Jun;41(3):101085. doi: 10.1016/j.accpm.2022.101085. Epub 2022 Apr 26. — View Citation

Mitra S, Khandelwal P, Sehgal A. Diclofenac-tramadol vs. diclofenac-acetaminophen combinations for pain relief after caesarean section. Acta Anaesthesiol Scand. 2012 Jul;56(6):706-11. doi: 10.1111/j.1399-6576.2012.02663.x. Epub 2012 Mar 5. — View Citation

Moonesinghe SR, Jackson AIR, Boney O, Stevenson N, Chan MTV, Cook TM, Lane-Fall M, Kalkman C, Neuman MD, Nilsson U, Shulman M, Myles PS; Standardised Endpoints in Perioperative Medicine-Core Outcome Measures in Perioperative and Anaesthetic Care (StEP-COMPAC) Group. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: patient-centred outcomes. Br J Anaesth. 2019 Nov;123(5):664-670. doi: 10.1016/j.bja.2019.07.020. Epub 2019 Sep 5. — View Citation

Morales-Ariza V, Loaiza-Aldean Y, de Miguel M, Pena-Navarro M, Martinez-Silva O, Gonzalez-Tallada A, Manrique-Munoz S, de Nadal M. Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study. Am J Surg. 2023 Apr;225(4):740-747. doi: 10.1016/j.amjsurg.2022.11.009. Epub 2022 Nov 17. — View Citation

Myles PS, Boney O, Botti M, Cyna AM, Gan TJ, Jensen MP, Kehlet H, Kurz A, De Oliveira GS Jr, Peyton P, Sessler DI, Tramer MR, Wu CL; StEP-COMPAC Group; Myles P, Grocott M, Biccard B, Blazeby J, Boney O, Chan M, Diouf E, Fleisher L, Kalkman C, Kurz A, Moonesinghe R, Wijeysundera D. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort. Br J Anaesth. 2018 Apr;120(4):705-711. doi: 10.1016/j.bja.2017.12.037. Epub 2018 Feb 2. — View Citation

Nnacheta TE, Onyekwulu FA, Amucheazi AO. Prevention of postanesthetic shivering under subarachnoid block for cesarean section: A randomized, controlled study comparing tramadol versus ondansetron. Niger J Clin Pract. 2020 May;23(5):619-625. doi: 10.4103/njcp.njcp_641_18. — View Citation

Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available. — View Citation

Richez B, Ouchchane L, Guttmann A, Mirault F, Bonnin M, Noudem Y, Cognet V, Dalmas AF, Brisebrat L, Andant N, Soule-Sonneville S, Dubray C, Duale C, Schoeffler P. The Role of Psychological Factors in Persistent Pain After Cesarean Delivery. J Pain. 2015 Nov;16(11):1136-46. doi: 10.1016/j.jpain.2015.08.001. Epub 2015 Aug 20. — View Citation

Sahmeddini MA, Azemati S, Motlagh EM. Local Infiltration of Tramadol versus Bupivacaine for Post Cesarean Section Pain Control: A Double-Blind Randomized Study. Iran J Med Sci. 2017 May;42(3):235-241. — View Citation

Sammour RN, Ohel G, Cohen M, Gonen R. Oral naproxen versus oral tramadol for analgesia after cesarean delivery. Int J Gynaecol Obstet. 2011 May;113(2):144-7. doi: 10.1016/j.ijgo.2010.11.024. — View Citation

Siddik-Sayyid S, Aouad-Maroun M, Sleiman D, Sfeir M, Baraka A. Epidural tramadol for postoperative pain after Cesarean section. Can J Anaesth. 1999 Aug;46(8):731-5. doi: 10.1007/BF03013907. — View Citation

Sultan P, Kamath N, Carvalho B, Bansal P, Elkhateb R, Dougan S, Whittington J, Guo N, El-Sayed Y, Mhyre J, Sharawi N. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100202. doi: 10.1016/j.ajogmf.2020.100202. Epub 2020 Aug 17. — View Citation

Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20. — View Citation

Vercauteren M, Vereecken K, La Malfa M, Coppejans H, Adriaensen H. Cost-effectiveness of analgesia after Caesarean section. A comparison of intrathecal morphine and epidural PCA. Acta Anaesthesiol Scand. 2002 Jan;46(1):85-9. doi: 10.1034/j.1399-6576.2002.460115.x. — View Citation

Weibel S, Neubert K, Jelting Y, Meissner W, Wockel A, Roewer N, Kranke P. Incidence and severity of chronic pain after caesarean section: A systematic review with meta-analysis. Eur J Anaesthesiol. 2016 Nov;33(11):853-865. doi: 10.1097/EJA.0000000000000535. — View Citation

Wu Z, Zhao P, Peng J, Fang L, Ding J, Yan G, Wang Y, Zhu J, Wang D, Li Y, Chen Z, Zhang Q, Deng Q, Duan G, Zuo Z, Li H. A Patient-Controlled Intravenous Analgesia With Tramadol Ameliorates Postpartum Depression in High-Risk Woman After Cesarean Section: A Randomized Controlled Trial. Front Med (Lausanne). 2021 May 27;8:679159. doi: 10.3389/fmed.2021.679159. eCollection 2021. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-surgical recovery	QoR-15 score at 24 hours after cesarean section	Day 1
Secondary	Analgesia for acute pain	Pain score evolution on the sequential Visual Analogue Scale at 24 hours, measured every 4 hours.	Day 1
Secondary	Adverse effects	Presence or absence of the next adverse effects: Pruritus; tremors; urinary retention or need for a bladder catheter; Constipation or abdominal distension; limitation of mobility; delayed initiation of breastfeeding if desired (due to analgesia); need for blood extraction for control analysis.	Day 1
Secondary	External validity of ObsQoR10 - Spanish version	ObsQor-10 score at 24 hours.	Day 1
Secondary	Post-surgical recovery	QoR-15 score at 48 hours after cesarean section	Day 2
Secondary	Adverse effects	Presence or absence of the next adverse effects: Pruritus; tremors; urinary retention or need for a bladder catheter; Constipation or abdominal distension; limitation of mobility; delayed initiation of breastfeeding if desired (due to analgesia); need for blood extraction for control analysis.	Day 2
Secondary	Analgesia for acute pain	Pain score evolution on the sequential Visual Analogue Scale at 48 hours, measured every 4 hours.	Day 2
Secondary	Chronic Pain	Chronic pain measured by numerical rating scale at 90 days of TRON versus AL-EPI.	Day 90