Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSohag University
About this trial
This study evaluates whether combining two distinct pain-relief techniques-a peripheral nerve block called the Erector Spinae Plane Block (ESPB) and a low-dose spinal medication injection called Intrathecal Morphine (ITM)-provides better postoperative pain management for adult patients undergoing major midline abdominal surgery (laparotomy) compared to using either technique alone. The main goal is to see if this combination improves pain control and reduces the total amount of opioids required by patients within the first 48 hours after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Intrathecal Morphine
DrugAdministration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision."
Erector Spinae Plane Block
Procedure/SurgeryBilateral ultrasound-guided erector spinae plane block performed at the T8-T10 level using a local anesthetic solution (such as bupivacaine or ropivacaine) injected deep to the erector spinae muscle fascia for postoperative abdominal analgesia.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Intrathecal morphine aloneActive comparator 1 intervention
Group B: Bilateral Erector Spinae Plane BlockActive comparator 1 intervention
Group C: Intrathecal morphine + Bilateral Erector Spinae Plane BlockExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Time to First Rescue Analgesia
Duration of time (in minutes/hours) elapsed from PACU admission to the patient's first request for an IV morphine rescue bolus.
Time frame
Up to 48 hours postoperatively.2
Postoperative Pain Intensity
Numeric Rating Scale (NRS) score ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame
At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.3
Cumulative Opioid Consumption
Total postoperative intravenous rescue morphine consumed, calculated and recorded in Morphine Milligram Equivalents (MME).
Time frame
Up to 48 hours postoperatively.Secondary outcomes
1
Time to First Ambulation
Time taken (in hours) from the end of surgery until the patient is able to walk more than 5 meters with assistance.
Time frame
Up to hospital discharge (typically up to 7 days).2
Time to Readiness for PACU Discharge
Time in minutes from PACU admission until the patient achieves a modified Aldrete score \\ge9.
Time frame
Within the first 24 hours postoperatively.3
Incidence of Adverse Events
Presence or absence (percentages) of respiratory depression (RR \<8/min or SpO\_2 \<90% on room air), PONV requiring treatment, or pruritus requiring treatment.
Time frame
Up to 48 hours postoperatively.4
Patient Satisfaction with Pain Management
Score on a 5-point Likert scale ranging from 1 (Dissatisfied) to 5 (Very Satisfied).
Time frame
Assessed at 48 hours postoperatively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov