Pain Management, Postoperative Analgesia
Conditions
Keywords
intrathecal morphine, rectus sheath block, lower abdominal surgery, postoperative analgesia
Brief summary
This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort. In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements. The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.
Detailed description
This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort. In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements. The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.
Interventions
PROCEDUREIntrathecal Morphine
Patients in this group will receive 200 mcg of intrathecal morphine administered at the L3-L4 interspace prior to general anesthesia as part of their perioperative analgesic regimen for postoperative pain control following lower abdominal surgery with a midline incision. As part of standard perioperative care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher.
PROCEDURERectus Sheath Block
Patients in this group will receive a bilateral rectus sheath block after induction of general anesthesia but prior to surgical incision, with 20 ml solution (10 ml of 0.25% bupivacaine and 10 ml of normal saline) administered to each side, in addition to standard perioperative analgesia. As part of standard care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old * Patients undergoing lower abdominal surgery via midline incision.
Exclusion criteria
* Patients with solid organ dysfunction * Patients who receive opioid or corticosteroid medication prior to surgery * Patients with bleeding diathesis * Patients with psychiatric disorders * Patients who can not be contacted after surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 24 hours postoperatively | The total amount of intravenous tramadol administered during the first 24 hours after surgery will be recorded to evaluate postoperative analgesic requirements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QoR-15 score | preoperative baseline and 24 hours postoperatively | Quality of recovery (QoR) will be assessed using the validated QoR-15 questionnaire both preoperatively and at 24 hours after surgery. The primary analysis will evaluate the change in score from baseline to 24 hours. The total score ranges from 0 (very poor recovery) to 150 (excellent recovery). |
| NRS Score | 24 hours postoperatively | Postoperative pain will be assessed using the Numeric Rating Scale (NRS: 0= no pain to 10= worst pain) at 24 hours after surgery. |
| Functional recovery | 24 hours postoperatively | Functional recovery will be assessed by recording the time to first mobilization, time to first oral intake, and time to return of bowel function within the first 24 hours after surgery. |
| Rescue Analgesic Consumption | 24 hours postoperatively | Total amount of rescue analgesics (intravenous morphine) administered within the first 24 hours postoperatively will be recorded. |
Countries
Turkey (Türkiye)
Outcome results
None listed