Acute Post-operative Pain Following Caesarean SectionOFAAPPCSNCT04539249
Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section
A study testing Magnesium sulphate and Pentazocine in people with Acute Post-operative Pain Following Caesarean Section, run by Olakunle Ifeoluwa Makinde at 1 site in Nigeria.
Trial summary
Background: Multimodal analgesia; a combination of opioid and non-opioid analgesics, for management of acute post-operative pain significantly reduces the incidence of adverse effects associated with liberal post-operative opioid use including sedation, respiratory depression, constipation, ileus, urinary retention… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Acute Post-operative Pain Following Caesarean Section
- What is being tested?
- Magnesium sulphate and Pentazocine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteNigeria
- Study dates
- 4 Nov 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women booked for elective, scheduled and urgent caesarean section at the Federal Medical Centre, Yenagoa, Bayelsa State during the study period,
- Pregnant women who give consent to participate in the study.
Who cannot join
- Pregnant women with active peptic ulcer disease, active liver disease, hepatic failure, and renal failure,
- Pregnant women with previous history of ischaemic heart disease/myocardial infarction, heart failure, venous thrombosis and stroke,
- Hypersensitivity to pentazocine, paracetamol, diclofenac or magnesium sulphate,
- Pregnant women with history of non-medical use (abuse) of opioids,
- Pregnant women on magnesium sulphate or have a clinical indication to receive magnesium sulphate,
- Pregnant women booked for emergency caesarean section (because the urgency may not allow time for adequate patient counseling before recruitment)
- Pregnant women booked for caesarean section under general anaesthesia or epidural anaesthesia,
- Pregnant women who can neither communicate in english nor colloquial english.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-centre, Randomized, Clinical Trial of Opioid-free Analgesia Versus Routine Opioid-based Analgesia Regimen for the Management of Acute Post-operative Pain Following Caesarean Section
Background: Multimodal analgesia; a combination of opioid and non-opioid analgesics, for management of acute post-operative pain significantly reduces the incidence of adverse effects associated with liberal post-operative opioid use including sedation, respiratory depression, constipation, ileus, urinary retention, delayed recovery, addiction etc. However, opioid addiction remains a worsening public health problem and have followed administration of opioid analgesics for post-operative pain and subsequent chronic use in many addicts; especially the opioid naive. Caesarean section is a commonly performed surgery and is a common source of first exposure to opioids in women. Trend in post-operative analgesia is moving towards opioid-free (multimodal) analgesia; a combination of non-opioid and adjuvant analgesics. Magnesium sulphate is an adjuvant analgesic. When administered peri-operatively, it has been reported to prolong the duration of spinal anaesthesia, decrease post-operative pain and opioid use without adverse effect.
Aim: To determine the effectiveness and safety of a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac as opioid-free, multimodal analgesia for management of acute post-operative pain after a caesarean section.
Read more
Null Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is not as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting.
Alternate Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting.
Materials and Methods: A randomized clinical trial, comparing a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac with an opioid-based multimodal regimen as control. Eligible patients will be consecutively selected from among women booked for caesarean section at the Federal Medical Centre, Yenagoa. Control group will receive a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac. Pain intensity will be determined in both groups and compared. Need for rescue opioid analgesic will be determined in both groups and compared. Incidence of any adverse event in both groups will be determined.
- Being tested
- Magnesium sulphate, Pentazocine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
Also called MgSO4
1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
PentazocineDrug
Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate | Experimental | Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac Receives: Drug: Magnesium sulphate |
| Pentazocine | Active comparator | Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac Receives: Drug: Pentazocine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative
Post-operative pain scores following caesarean section at 4 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Measured: 4 hours post-operative
Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative
Post-operative pain scores following caesarean section at 8 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Measured: 8 hours post-operative
Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative
Post-operative pain scores following caesarean section at 24 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Measured: 24 hours post-operative
Post-operative Pentazocine Use
Whether or not Pentazocine was used post-operatively
Measured: 24 hours post-operative
Pentazocine Use as Rescue Analgesia
Whether or not pentazocine was used as rescue analgesia
Measured: 24 hours post-operative
Frequency and Nature of Pentazocine Use
Frequency of Pentazocine use per participant in each arm of the study and whether it was used as indicated in the protocol and/or for rescue analgesia
Measured: 24 hours post-operative
Mean Dose of Pentazocine Used
Mean dose of Pentazocine used in each arm of the study
Measured: 24 hours post-operative
Secondary outcomes (3)
Number of Participants With Peri-operative Adverse Events
Number of participants with peri-operative adverse events including hypersensitivity reaction, respiratory depression, bradycardia, hypotension, nausea and vomiting, lightheadedness, presyncope, and any other adverse event recorded from the time of first administration of peri-operative analgesia to 2 hours postoperative
Measured: Time of first administration of peri-operative analgesia to 2 hours postoperative
Number of Participants With Post-operative Adverse Events
Number of participants with post-operative adverse events including respiratory depression constipation, ileus, pruritus, urinary retention and any other adverse event recorded during the first 24 hours post-operative.
Measured: First 24 hours post-operative
Apgar Scores of the Neonates
Apgar scores of the neonates delivered by the women who had caesarean section under the study, taken at first and fifth minutes after birth. Apgar score has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a better outcome (0-3= low Apgar score, 4-6= moderately abnormal Apgar score and 7-10= reassuring Apgar score
Measured: At first and fifth minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start4 Nov 2020
- Primary completion30 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Post-operative Pain Following Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olakunle Ifeoluwa Makinde
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Olakunle Ifeoluwa Makinde, Federal Medical Centre, Yenagoa
- Investigators
- Olakunle I Makinde, MBChB, MWACS, Principal investigator, Federal Medical Centre, Yenagoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539249
- Sponsor's protocol ID
- FMCY/O&G/OFAAPPCS/2020
- Acronym
- OFAAPPCS
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2020
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data that underlie results in a publication
Publications
Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014.
PubMed 24872720Kim M. An opioid success story: efforts to minimize painkillers after surgery appear to be working. Johannesburg, South Africa: The Conversation Africa, Inc.; 2019.
Johnson SR. Hospitals look to cut opioids from surgery and beyond. Detroit, Michigan: Crain communications, Inc.; 2019.
Dinis J, Soto E, Pedroza C, Chauhan SP, Blackwell S, Sibai B. Nonopioid versus opioid analgesia after hospital discharge following cesarean delivery: a randomized equivalence trial. Am J Obstet Gynecol. 2020 May;222(5):488.e1-488.e8. doi: 10.1016/j.ajog.2019.12.001. Epub 2019 Dec 6.
PubMed 31816306Kahraman F, Eroglu A. The effect of intravenous magnesium sulfate infusion on sensory spinal block and postoperative pain score in abdominal hysterectomy. Biomed Res Int. 2014;2014:236024. doi: 10.1155/2014/236024. Epub 2014 Mar 19.
PubMed 24772415McKeown A, Seppi V, Hodgson R. Intravenous Magnesium Sulphate for Analgesia after Caesarean Section: A Systematic Review. Anesthesiol Res Pract. 2017;2017:9186374. doi: 10.1155/2017/9186374. Epub 2017 Dec 3.
PubMed 29333156Shin HJ, Kim EY, Na HS, Kim TK, Kim MH, Do SH. Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Br J Anaesth. 2016 Oct;117(4):497-503. doi: 10.1093/bja/aew227. Epub 2016 Oct 17.
PubMed 28077538Kalani N, Sanie MS, Zabetian H, Radmehr M, Sahraei R, Kargar Jahromi H, Zare Marzouni H. Comparison of the Analgesic Effect of Paracetamol and Magnesium Sulfate during Surgeries. World J Plast Surg. 2016 Sep;5(3):280-286.
PubMed 27853692Murphy JD, Paskaradevan J, Eisler LL, Ouanes JP, Tomas VA, Freck EA, Wu CL. Analgesic efficacy of continuous intravenous magnesium infusion as an adjuvant to morphine for postoperative analgesia: a systematic review and meta-analysis. Middle East J Anaesthesiol. 2013 Feb;22(1):11-20.
PubMed 23833845Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
PubMed 23121612Hwang JY, Na HS, Jeon YT, Ro YJ, Kim CS, Do SH. I.V. infusion of magnesium sulphate during spinal anaesthesia improves postoperative analgesia. Br J Anaesth. 2010 Jan;104(1):89-93. doi: 10.1093/bja/aep334.
PubMed 19933175Apan A, Buyukkocak U, Ozcan S, Sari E, Basar H. Postoperative magnesium sulphate infusion reduces analgesic requirements in spinal anaesthesia. Eur J Anaesthesiol. 2004 Oct;21(10):766-9. doi: 10.1017/s026502150400002x.
PubMed 15678729Helmy N, Badawy AA, Hussein M, Reda H. Comparison of the preemptive analgesia of low dose ketamine versus magnesium sulphate on parturient undergoing caesarean section under general anaesthesia. Egypt. J. Anaesth. 2015;31(1):53-58.
Paech MJ, Magann EF, Doherty DA, Verity LJ, Newnham JP. Does magnesium sulfate reduce the short- and long-term requirements for pain relief after caesarean delivery? A double-blind placebo-controlled trial. Am J Obstet Gynecol. 2006 Jun;194(6):1596-602; discussion 1602-3. doi: 10.1016/j.ajog.2006.01.009. Epub 2006 Apr 17.
PubMed 16615926
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Randomized, Clinical Trial of Opioid-free Analgesia Versus Routine Opioid-based Analgesia Regimen for the Management of Acute Post-operative Pain Following Caesarean Section
- ClinicalTrials.gov ID
- NCT04539249
- Acronym / sponsor ID
- OFAAPPCS / FMCY/O&G/OFAAPPCS/2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Olakunle Ifeoluwa MakindeOther government
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Posted 20 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Multimodal analgesia; a combination of opioid and non-opioid analgesics, for management of acute post-operative pain significantly reduces the incidence of adverse effects associated with liberal post-operative opioid use including sedation, respiratory depression, constipation, ileus, urinary retention, delayed recovery, addiction etc. However, opioid addiction remains a worsening public health problem and have followed administration of opioid analgesics for post-operative pain and subsequent chronic use in many addicts; especially the opioid naive. Caesarean section is a commonly performed surgery and is a common source of first exposure to opioids in women. Trend in post-operative analgesia is moving towards opioid-free (multimodal) analgesia; a combination of non-opioid and adjuvant analgesics. Magnesium sulphate is an adjuvant analgesic. When administered peri-operatively, it has been reported to prolong the duration of spinal anaesthesia, decrease post-operative pain and opioid use without adverse effect.
Aim: To determine the effectiveness and safety of a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac as opioid-free, multimodal analgesia for management of acute post-operative pain after a caesarean section.
Null Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is not as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting.
Alternate Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting.
Materials and Methods: A randomized clinical trial, comparing a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac with an opioid-based multimodal regimen as control. Eligible patients will be consecutively selected from among women booked for caesarean section at the Federal Medical Centre, Yenagoa. Control group will receive a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac. Pain intensity will be determined in both groups and compared. Need for rescue opioid analgesic will be determined in both groups and compared. Incidence of any adverse event in both groups will be determined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate | Experimental | Drug: Magnesium sulphateCombination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac |
| Pentazocine | Active comparator | Drug: PentazocineCombination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women booked for elective, scheduled and urgent caesarean section at the Federal Medical Centre, Yenagoa, Bayelsa State during the study period,
- Pregnant women who give consent to participate in the study.
Key exclusion criteria (8 listed)
- Pregnant women with active peptic ulcer disease, active liver disease, hepatic failure, and renal failure,
- Pregnant women with previous history of ischaemic heart disease/myocardial infarction, heart failure, venous thrombosis and stroke,
- Hypersensitivity to pentazocine, paracetamol, diclofenac or magnesium sulphate,
- Pregnant women with history of non-medical use (abuse) of opioids,
- Pregnant women on magnesium sulphate or have a clinical indication to receive magnesium sulphate,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulphateAlso: MgSO41g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours. N.B: Intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section. | Drug | Magnesium sulphate |
| PentazocinePost-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours. N.B: Intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section. | Drug | Pentazocine |
Primary outcome
Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative
Time frame: 4 hours post-operative
Post-operative pain scores following caesarean section at 4 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative
Time frame: 8 hours post-operative
Post-operative pain scores following caesarean section at 8 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative
Time frame: 24 hours post-operative
Post-operative pain scores following caesarean section at 24 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Post-operative Pentazocine Use
Time frame: 24 hours post-operative
Whether or not Pentazocine was used post-operatively
Pentazocine Use as Rescue Analgesia
Time frame: 24 hours post-operative
Whether or not pentazocine was used as rescue analgesia
Frequency and Nature of Pentazocine Use
Time frame: 24 hours post-operative
Frequency of Pentazocine use per participant in each arm of the study and whether it was used as indicated in the protocol and/or for rescue analgesia
Mean Dose of Pentazocine Used
Time frame: 24 hours post-operative
Mean dose of Pentazocine used in each arm of the study
3 secondary outcomes
Number of Participants With Peri-operative Adverse Events
Time frame: Time of first administration of peri-operative analgesia to 2 hours postoperative
Number of Participants With Post-operative Adverse Events
Time frame: First 24 hours post-operative
Apgar Scores of the Neonates
Time frame: At first and fifth minutes after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24872720Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014.
- BackgroundKim M. An opioid success story: efforts to minimize painkillers after surgery appear to be working. Johannesburg, South Africa: The Conversation Africa, Inc.; 2019.
- BackgroundJohnson SR. Hospitals look to cut opioids from surgery and beyond. Detroit, Michigan: Crain communications, Inc.; 2019.
- Background: PubMed 31816306Dinis J, Soto E, Pedroza C, Chauhan SP, Blackwell S, Sibai B. Nonopioid versus opioid analgesia after hospital discharge following cesarean delivery: a randomized equivalence trial. Am J Obstet Gynecol. 2020 May;222(5):488.e1-488.e8. doi: 10.1016/j.ajog.2019.12.001. Epub 2019 Dec 6.
- Background: PubMed 24772415Kahraman F, Eroglu A. The effect of intravenous magnesium sulfate infusion on sensory spinal block and postoperative pain score in abdominal hysterectomy. Biomed Res Int. 2014;2014:236024. doi: 10.1155/2014/236024. Epub 2014 Mar 19.
- Background: PubMed 29333156McKeown A, Seppi V, Hodgson R. Intravenous Magnesium Sulphate for Analgesia after Caesarean Section: A Systematic Review. Anesthesiol Res Pract. 2017;2017:9186374. doi: 10.1155/2017/9186374. Epub 2017 Dec 3.
- Background: PubMed 28077538Shin HJ, Kim EY, Na HS, Kim TK, Kim MH, Do SH. Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Br J Anaesth. 2016 Oct;117(4):497-503. doi: 10.1093/bja/aew227. Epub 2016 Oct 17.
- Background: PubMed 27853692Kalani N, Sanie MS, Zabetian H, Radmehr M, Sahraei R, Kargar Jahromi H, Zare Marzouni H. Comparison of the Analgesic Effect of Paracetamol and Magnesium Sulfate during Surgeries. World J Plast Surg. 2016 Sep;5(3):280-286.
- Background: PubMed 23833845Murphy JD, Paskaradevan J, Eisler LL, Ouanes JP, Tomas VA, Freck EA, Wu CL. Analgesic efficacy of continuous intravenous magnesium infusion as an adjuvant to morphine for postoperative analgesia: a systematic review and meta-analysis. Middle East J Anaesthesiol. 2013 Feb;22(1):11-20.
- Background: PubMed 23121612Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
- Background: PubMed 19933175Hwang JY, Na HS, Jeon YT, Ro YJ, Kim CS, Do SH. I.V. infusion of magnesium sulphate during spinal anaesthesia improves postoperative analgesia. Br J Anaesth. 2010 Jan;104(1):89-93. doi: 10.1093/bja/aep334.
- Background: PubMed 15678729Apan A, Buyukkocak U, Ozcan S, Sari E, Basar H. Postoperative magnesium sulphate infusion reduces analgesic requirements in spinal anaesthesia. Eur J Anaesthesiol. 2004 Oct;21(10):766-9. doi: 10.1017/s026502150400002x.
- Individual participant dataSharing planned: Yes. All Individual Participant Data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olakunle I Makinde, MBChB, MWACS principal investigator
Federal Medical Centre, Yenagoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulphate and Pentazocine in people with Acute Post-operative Pain Following Caesarean Section, run by Olakunle Ifeoluwa Makinde at 1 site in Nigeria.
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 2 inclusion and 8 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 20 Jul 2023. 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 Nigeria. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative (time frame: 4 hours post-operative). The study lists 7 primary outcomes in all. 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 NCT04539249, which also lists 14 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 20 Jul 2023.