A Phase 2/3 interventional study of Intravenous normal saline and Intraperitoneal normal saline in Postcesarean Pain Relief, sponsored by Benha University. Completed. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-03-14.
Sponsored by Benha University · Phase 2/3, Interventional, and Treatment
Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section.
Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.
Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Saline was given both intraperitoneally and intravenously during caesarean section
Drug: Intravenous normal saline · Drug: Intraperitoneal normal saline
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding.
Drug: Intravenous normal saline · Drug: Intraperitoneal Lidocaine
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding
Drug: Intraperitoneal normal saline · Drug: Intravenous Lidocaine
Normal saline in a volume equivalent to that used in intravenous lidocaine group
Also known as: IV Saline
Patients received 00 ml of saline intraperitoneally
Also known as: IP Saline
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.
Also known as: IP Lidocaine
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery.
Also known as: IV Lidocaine
Postoperative pain scoring (number)
Time frame: First 24 hours postoperative
The need for rescue postoperative analgesia.
Time frame: First 24 hours postoperative
Total pethidine consumption in 24 hours (mg)
Time frame: First 24 hours postoperative
The time to bowel sounds, hours
Time frame: First 3 days postoperative
The time to start regular diet, days
Time frame: First 3 days postoperative
Duration of hospital stay , days
Time frame: First 3 days postoperative
Any reported side effects
Time frame: First 3 days postoperative
No study locations are listed for this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Benha University