Pain Management
Conditions
Brief summary
Hip fracture surgery is commonly associated with moderate to severe postoperative pain, which may delay mobilization and increase the need for opioid analgesics. The deep iliacus plane block is a recently described ultrasound-guided regional anesthesia technique designed to provide analgesia by allowing local anesthetic spread toward the femoral nerve, lateral femoral cutaneous nerve, and articular branches supplying the hip. This prospective, randomized, double-blind, sham-controlled clinical trial will evaluate the analgesic efficacy of the deep iliacus plane block in adult patients undergoing hip fracture surgery under spinal anesthesia. After surgery, participants will be randomly assigned to receive either an ultrasound-guided deep iliacus plane block with local anesthetic or a sham block with normal saline. All participants will receive standardized multimodal postoperative analgesia, including patient-controlled analgesia. The primary objective is to determine whether the deep iliacus plane block reduces postoperative opioid consumption during the first 24 hours after surgery. Postoperative pain scores, rescue analgesic requirements, sensory distribution, motor block, nausea and vomiting, quality of recovery, patient satisfaction, and block-related complications will also be evaluated.
Detailed description
This study is designed as a prospective, randomized, double-blind, sham-controlled clinical trial involving adult patients undergoing hip fracture surgery under spinal anesthesia. Eligible participants will receive standard monitoring in accordance with the American Society of Anesthesiologists recommendations, including electrocardiography, noninvasive blood pressure measurement, and pulse oximetry. Spinal anesthesia will be performed under sterile conditions at the L3-L4 intervertebral level using 15 mg of isobaric bupivacaine. Following completion of surgery, while the sensory effects of spinal anesthesia are still present, participants will be randomly allocated to one of two parallel study groups. Randomization will be performed using a computer-generated allocation sequence, and group assignments will be concealed using sequentially prepared sealed envelopes. Participants assigned to the intervention group will receive an ultrasound-guided deep iliacus plane block on the surgical side. A low-frequency curvilinear ultrasound transducer will be positioned over the anterior hip region to identify the anterior inferior iliac spine, iliopubic eminence, iliopsoas muscle, psoas tendon, femoral nerve, and adjacent vascular structures. After identification of the target plane between the iliopsoas muscle and the anterior inferior iliac spine, a peripheral nerve block needle will be advanced using an in-plane approach. Following confirmation of appropriate needle-tip position, 30 mL of 0.25% bupivacaine will be administered. Participants assigned to the control group will undergo an identical ultrasound-guided procedure and will receive 30 mL of normal saline as a sham block. Participants and postoperative outcome assessors will remain blinded to group allocation. The anesthesiologist performing the study intervention will not participate in postoperative outcome assessment. All participants will receive a standardized multimodal postoperative analgesic regimen. Intravenous patient-controlled analgesia will contain tramadol at a concentration of 4 mg/mL, without a background infusion. The device will deliver 20 mg tramadol per patient-initiated bolus, with a 20-minute lockout interval and a maximum dose of 200 mg over four hours. Intravenous paracetamol 1 g will be administered routinely at the sixth postoperative hour. Intravenous dexketoprofen 50 mg will be provided as rescue analgesia when clinically required. The primary outcome will be cumulative tramadol consumption during the first 24 postoperative hours. Pain intensity will be evaluated using the 0-10 Numerical Rating Scale, where 0 represents no pain and 10 represents the worst imaginable pain. Pain scores at rest and during movement will be recorded at predefined postoperative time points. The sensory distribution of the block will be assessed approximately two hours after surgery, after resolution of the residual sensory effects of spinal anesthesia. Cold sensation will be evaluated using an alcohol-based swab over relevant lower-extremity and abdominal dermatomes. Participants will be asked to report any reduction, alteration, or loss of cold sensation compared with unaffected areas. Additional outcomes will include rescue analgesic requirements, time to first rescue analgesia, patient-controlled analgesia demand frequency, presence and severity of motor block, postoperative nausea and vomiting, antiemetic requirements, block performance time, block-related complications, patient satisfaction, quality of recovery assessed using the Quality of Recovery-15 questionnaire at 24 hours, and duration of hospital stay. The study aims to determine whether adding the deep iliacus plane block to standardized multimodal analgesia provides superior postoperative analgesia and reduces opioid requirements compared with standardized multimodal analgesia combined with a sham block.
Interventions
PROCEDUREUltrasound-Guided Deep Iliacus Plane Block With Bupivacaine
Following completion of surgery, participants will receive an ultrasound-guided unilateral deep iliacus plane block on the surgical side. A low-frequency curvilinear ultrasound transducer will be used to identify the anterior inferior iliac spine, iliopsoas muscle, psoas tendon, femoral nerve, and adjacent vascular structures. A 22-gauge, 100-mm block needle will be advanced using an in-plane approach into the target plane between the iliopsoas muscle and the anterior inferior iliac spine. After confirmation of the appropriate needle-tip position, 30 mL of 0.25% bupivacaine will be administered.
PROCEDURESham Deep Iliacus Plane Block With Normal Saline
Participants will undergo an identical ultrasound-guided unilateral deep iliacus plane block procedure on the surgical side. The same anatomical landmarks, ultrasound approach, needle type, and target plane will be used. After confirmation of the appropriate needle-tip position, 30 mL of normal saline will be administered as the sham intervention.
Sponsors
Kanuni Sultan Suleyman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and postoperative outcome assessors will be masked to group allocation. Both groups will undergo an identical ultrasound-guided deep iliacus plane block procedure. The anesthesiologist performing the block will be aware of the allocated intervention but will not participate in postoperative outcome assessment. Group allocation will remain concealed from participants and outcome assessors until completion of data collection, except when emergency unmasking is required for participant safety.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Scheduled to undergo unilateral hip fracture surgery under spinal anesthesia * American Society of Anesthesiologists (ASA) physical status I-III * Ability to understand and use the Numerical Rating Scale and patient-controlled analgesia device * No contraindication to spinal anesthesia or the deep iliacus plane block * Written informed consent provided by the participant or legally authorized representative
Exclusion criteria
* ASA physical status IV or higher * Emergency surgery * Coagulopathy, bleeding diathesis, or anticoagulant treatment that contraindicates spinal anesthesia or peripheral nerve block * Infection at the planned needle insertion site * Known allergy to local anesthetics or any study medication * Pre-existing peripheral neuropathy, neurological disorder, or motor deficit involving the operated lower extremity * Inability to understand or use the Numerical Rating Scale or patient-controlled analgesia device * Cognitive impairment or communication difficulty preventing reliable postoperative assessment * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Tramadol Consumption During the First 24 Postoperative Hours | From completion of surgery to postoperative hour 24 | The total amount of tramadol, expressed in milligrams, delivered by the intravenous patient-controlled analgesia device during the first 24 hours after surgery will be recorded. The patient-controlled analgesia solution will contain tramadol at a concentration of 4 mg/mL, with a 20 mg bolus dose, a 20-minute lockout interval, no background infusion, and a maximum limit of 200 mg over four hours. Lower cumulative consumption indicates a lower postoperative opioid requirement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Numerical Rating Scale Pain Scores at Rest | At postoperative hours 1, 6, 12, and 24 | Postoperative pain intensity at rest will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Scores will be recorded separately at each predefined postoperative assessment time. |
| Postoperative Numerical Rating Scale Pain Scores During Movement | At postoperative hours 1, 6, 12, and 24 | Postoperative pain intensity during movement will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Scores will be recorded separately at each predefined postoperative assessment time. |
| Requirement for Rescue Analgesia During the First 24 Postoperative Hours | During the first 24 postoperative hours | The number and proportion of participants requiring at least one dose of rescue analgesia during the first 24 hours after surgery will be recorded. Intravenous dexketoprofen 50 mg will be administered as rescue analgesia when required despite the standardized multimodal analgesic regimen. |
| Cumulative Dexketoprofen Consumption During the First 24 Postoperative Hours | During the first 24 postoperative hours | The total amount of intravenous dexketoprofen administered as rescue analgesia during the first 24 hours after surgery will be recorded in milligrams. Each rescue dose will consist of 50 mg of intravenous dexketoprofen. |
| Dermatomal Distribution of Sensory Blockade Assessed by Cold Sensation | At postoperative hour 2 | The sensory distribution of the assigned intervention will be evaluated using a cold sensation test with ice cubes after the residual sensory effects of spinal anesthesia have resolved. Relevant lower-extremity and abdominal dermatomes will be assessed, and dermatomes showing reduced, altered, or absent cold sensation will be recorded. |
| Incidence of Postoperative Nausea and Vomiting | During the first 24 postoperative hours, assessed at hours 1, 6, 12, and 24 | The occurrence of nausea, vomiting, or both during the first 24 hours after surgery will be recorded. Results will be reported as the number and proportion of participants experiencing at least one episode of postoperative nausea or vomiting. |
| Quality of Recovery-15 Score at 24 Hours After Surgery | At postoperative hour 24 | Postoperative quality of recovery will be evaluated using the Turkish validated Quality of Recovery-15 questionnaire. The total questionnaire score will be recorded, with higher scores indicating better postoperative recovery. |
| Incidence of Postoperative Motor Block | At postoperative hours 6 and 24 | Quadriceps muscle strength in the operated lower extremity will be assessed using a six-point Manual Muscle Testing scale based on the participant's ability to actively extend the knee: 0, no detectable quadriceps muscle activity; 1, trace muscle activity without joint movement; 2, active knee extension possible only with gravity eliminated; 3, active knee extension against gravity but not against external resistance; 4, active knee extension against gravity and moderate manual resistance; and 5, normal muscle strength against full manual resistance. Higher scores indicate better preservation of quadriceps motor function. Assessments will be performed by an outcome assessor masked to group allocation. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEngin ihsan Turan, principal investigator
Outcome results
None listed