Anesthesia, RegionalCBFRNCT05734469
Difference in Occurrence of Rebound Pain in Patients Undergoing Surgery Under Popliteal Block or Ankle Block
A study testing Forefoot bone surgery in people with Anesthesia, Regional and Anesthesia and Analgesia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This single-center, prospective, randomized controlled trial compared rebound pain (RP) occurrence following popliteal sciatic nerve block versus ankle block in patients undergoing elective forefoot bone surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Regional, Anesthesia and Analgesia
- What is being tested?
- Forefoot bone surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Apr 2023to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any surgery of the bones of the lower limbs performed as part of a PNB associated with general anaesthesia after lower limb bone surgery
- Patient aged between 18 and 75 years old.
Who cannot join
- refusal to participate
- contraindication to the use of local anesthetics
- contraindication to the use of general anesthesia
- contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
- cognitive disorders
- inability to answer perioperative questionnaires (language problem).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rebound Pain Occurrence in Patients Undergoing Forefoot Bone Surgery Under Popliteal Sciatic Nerve Block or Distal Sensory Ankle Block: a Randomized Clinical Trial
This single-center, prospective, randomized controlled trial compared rebound pain (RP) occurrence following popliteal sciatic nerve block versus ankle block in patients undergoing elective forefoot bone surgery.
Patients were randomized to receive one of the two ultrasound-guided, single-injection peripheral nerve block techniques, combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion.
Read more
The primary objective was to compare RP incidence between the two block techniques. Secondary exploratory objectives included assessing postoperative pain trajectories and perioperative changes in skin temperature and tissue oxygen saturation as indirect indicators of local vasomotor and/or inflammatory responses.
Rebound pain was operationally defined as initially mild postoperative pain (NRS <4 at post-anesthesia care unit discharge), followed by severe pain (NRS ≥7) in the context of block resolution, typically described within 12-24 hours after block resolution. The exact interval between sensory recovery and severe pain onset was not systematically recorded.
Read the detailed description
This prospective, randomized, single-center controlled trial compared popliteal sciatic nerve block with ankle block in patients undergoing elective forefoot bone surgery. Participants were randomly allocated in a 1:1 ratio to either regional anesthetic technique, combined with standardized general anesthesia.
All peripheral nerve blocks were performed under ultrasound guidance before surgery using ropivacaine 0.5% with adrenaline (1:400,000) and clonidine (75 µg). Ankle blocks targeted the nerves supplying the surgical territory, while popliteal sciatic nerve blocks were supplemented by saphenous nerve blockade when required.
Before recruitment, the general anesthesia protocol was modified from the initially registered regimen involving sevoflurane maintenance to propofol target-controlled infusion for both induction and maintenance. This modification aimed to standardize anesthetic management and limit potential confounding effects on postoperative pain assessment. Sufentanil was reserved for intraoperative rescue analgesia but was not required. No intravenous ketamine, dexmedetomidine, or dexamethasone was administered.
Perioperative physiological assessments included infrared skin temperature measurements and tissue oxygen saturation monitoring using INVOS near-infrared spectroscopy on the operated and contralateral limbs. The originally planned Periflux measurements were discontinued before recruitment because the local heating required by this technique could interfere with skin temperature assessment. Preoperative hs-CRP and neutrophil-to-lymphocyte ratio measurements were performed, but the originally planned postoperative biomarker assessments were not conducted.
Postoperative analgesia was standardized using paracetamol and ibuprofen, with tramadol available as rescue medication. Patients remained hospitalized for approximately 24-48 hours, allowing clinical monitoring during sensory block regression and recovery. Follow-up assessments were conducted during hospitalization and by telephone on postoperative days 4 and 30 and at 3 months.
The study primarily compared rebound pain occurrence between the two regional anesthetic techniques. However, the exact onset of severe pain was not systematically timestamped, preventing reliable reconstruction of the originally registered 24-hour endpoint. The operational assessment and corresponding sensitivity analysis are specified in the Outcome Measures section.
- Conditions
- Anesthesia, Regional, Anesthesia and Analgesia
- Being tested
- Forefoot bone surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forefoot bone surgeryOther
Elective forefoot bone surgery under popliteal sciatic nerve
Forefoot bone surgeryOther
Elective forefoot bone surgery under an ankle block
| Study group | Role | What they receive |
|---|---|---|
| Popliteal sciatic nerve block | Other | An ultrasound-guided popliteal sciatic nerve block was performed using ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The popliteal block generally required 20-30 mL of local anesthetic solution. An additional ultrasound-guided saphenous nerve block was performed when indicated by the surgical territory, with total administered volumes reaching up to 40 mL. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg.
The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI). Receives: Other: Forefoot bone surgery |
| Ankle block | Other | An ultrasound-guided ankle block was performed using 15-20 mL of ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The block targeted the saphenous, superficial peroneal, deep peroneal, and tibial nerves. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg.
The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI). Receives: Other: Forefoot bone surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of rebound pain following peripheral nerve block resolution
Rebound pain was assessed as severe postoperative pain (NRS ≥7) following initially mild pain (NRS <4) at post-anesthesia care unit discharge, in the context of peripheral nerve block resolution. Incidence was compared between popliteal sciatic nerve block and ankle block groups. A sensitivity analysis used the stricter NRS >7 threshold. The exact onset of severe pain was not systematically timestamped; therefore, the originally registered 24-hour endpoint could not be reliably reconstructed.
Measured: During postoperative hospitalization (approximately 24-48 hours), including the period of sensory block resolution.
Secondary outcomes (11)
Perioperative changes in skin temperature
Skin temperature (°C) was measured using infrared thermometry on the operated and contralateral feet before and after peripheral nerve block, at emergence from general anesthesia, and on postoperative day 1. Changes over time and their association with rebound pain occurrence were explored.
Measured: Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Perioperative changes in tissue oxygen saturation
Tissue oxygen saturation (%) was measured using near-infrared spectroscopy (INVOS) on the operated and contralateral feet before and after peripheral nerve block, at emergence from general anesthesia, and on postoperative day 1. Changes over time and their association with rebound pain occurrence were explored.
Measured: Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Preoperative Pain Catastrophizing Scale (PCS) score
The Pain Catastrophizing Scale (PCS) was administered preoperatively to assess pain-related catastrophizing. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing. The PCS score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.
Measured: Preoperatively, before peripheral nerve block administration.
Preoperative Amsterdam Preoperative Anxiety and Information Scale (APAIS) score
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was administered preoperatively to assess anxiety and information needs related to anesthesia and surgery. The total APAIS score ranges from 6 to 30, with higher scores indicating greater preoperative anxiety and/or information needs. The total score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.
Measured: Preoperatively, before peripheral nerve block administration.
Preoperative Central Sensitization Inventory (CSI-9) score
The nine-item Central Sensitization Inventory (CSI-9) was administered preoperatively to assess symptoms associated with central sensitization. The total score ranges from 0 to 36, with higher scores indicating a greater burden of symptoms associated with central sensitization. The CSI-9 score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.
Measured: Preoperatively, before peripheral nerve block administration.
Preoperative DN4 questionnaire score
The Douleur Neuropathique en 4 Questions (DN4) questionnaire was administered preoperatively to assess neuropathic pain characteristics. The total score ranges from 0 to 10, with higher scores indicating more neuropathic pain features. A score of 4 or higher suggests a neuropathic pain component. The DN4 score was descriptively reported as a baseline patient characteristic and compared between the popliteal sciatic nerve block and ankle block groups.
Measured: Preoperatively, before peripheral nerve block administration.
Postoperative DN2 score at day 4
The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered on postoperative day 4 to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.
Measured: Postoperative day 4.
Postoperative DN2 score at day 30
The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered on postoperative day 30 to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.
Measured: Postoperative day 30.
Postoperative DN2 score at 3 months
The Douleur Neuropathique en 2 Questions (DN2) questionnaire was administered three months after surgery to assess neuropathic pain symptoms. The questionnaire comprises seven items derived from the DN4, each scored as present (1) or absent (0). The total score ranges from 0 to 7, with higher scores indicating more neuropathic pain symptoms. Scores were compared between the popliteal sciatic nerve block and ankle block groups.
Measured: 3 months after surgery.
Preoperative high-sensitivity C-reactive protein (hs-CRP) level
High-sensitivity C-reactive protein (hs-CRP) levels were measured preoperatively (mg/L) as an exploratory marker of baseline systemic inflammation. Values were descriptively compared between the popliteal sciatic nerve block and ankle block groups. Postoperative hs-CRP measurements originally planned in the study protocol were not performed.
Measured: Preoperatively, before surgery.
Preoperative neutrophil-to-lymphocyte ratio (NLR)
The neutrophil-to-lymphocyte ratio (NLR) was calculated from preoperative blood cell counts as an exploratory marker of baseline systemic inflammation. This dimensionless ratio was descriptively compared between the popliteal sciatic nerve block and ankle block groups. Postoperative NLR measurements originally planned in the study protocol were not performed.
Measured: Preoperatively, before surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start24 Apr 2023
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, RegionalStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nassim TOUIL, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734469
- Sponsor's protocol ID
- 2022/22SEP/352
- Acronym
- CBFR
- Status last verified
- Nov 2026
- First submitted
- 17 Jan 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
PubMed 33390261Streb T, Schneider A, Wiesmann T, Riecke J, Schubert AK, Dinges HC, Volberg C. [Rebound pain-From definition to treatment]. Anaesthesiologie. 2022 Aug;71(8):638-645. doi: 10.1007/s00101-022-01120-z. Epub 2022 May 5. German.
PubMed 35513729Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available.
PubMed 33551124Touil N, Pavlopoulou A, Barbier O, Libouton X, Lavand'homme P. Evaluation of intraoperative ketamine on the prevention of severe rebound pain upon cessation of peripheral nerve block: a prospective randomised, double-blind, placebo-controlled study. Br J Anaesth. 2022 Apr;128(4):734-741. doi: 10.1016/j.bja.2021.11.043. Epub 2022 Feb 23.
PubMed 35219449Sort R, Brorson S, Gogenur I, Nielsen JK, Moller AM. Rebound pain following peripheral nerve block anaesthesia in acute ankle fracture surgery: An exploratory pilot study. Acta Anaesthesiol Scand. 2019 Mar;63(3):396-402. doi: 10.1111/aas.13290. Epub 2018 Nov 8.
PubMed 30411313Sort R, Brorson S, Gogenur I, Hald LL, Nielsen JK, Salling N, Hougaard S, Foss NB, Tengberg PT, Klausen TW, Moller AM. Peripheral nerve block anaesthesia and postoperative pain in acute ankle fracture surgery: the AnAnkle randomised trial. Br J Anaesth. 2021 Apr;126(4):881-888. doi: 10.1016/j.bja.2020.12.037. Epub 2021 Feb 2.
PubMed 33546844Jen TTH, Ke JXC, Wing KJ, Denomme J, McIsaac DI, Huang SC, Ree RM, Prabhakar C, Schwarz SKW, Yarnold CH. Development and internal validation of a multivariable risk prediction model for severe rebound pain after foot and ankle surgery involving single-shot popliteal sciatic nerve block. Br J Anaesth. 2022 Jul;129(1):127-135. doi: 10.1016/j.bja.2022.03.030. Epub 2022 May 12.
PubMed 35568510Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. doi: 10.1097/BOT.0b013e3182638b25.
PubMed 22732860Yamada T, Hasegawa-Moriyama M, Kurimoto T, Saito T, Kuwaki T, Kanmura Y. Peripheral Nerve Block Facilitates Acute Inflammatory Responses Induced by Surgical Incision in Mice. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):593-600. doi: 10.1097/AAP.0000000000000458.
PubMed 27547899Tighe PJ, Elliott CE, Lucas SD, Boezaart AP. Noninvasive tissue oxygen saturation determined by near-infrared spectroscopy following peripheral nerve block. Acta Anaesthesiol Scand. 2011 Nov;55(10):1239-46. doi: 10.1111/j.1399-6576.2011.02533.x. Epub 2011 Sep 26.
PubMed 22092129
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebound Pain Occurrence in Patients Undergoing Forefoot Bone Surgery Under Popliteal Sciatic Nerve Block or Distal Sensory Ankle Block: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05734469
- Acronym / sponsor ID
- CBFR / 2022/22SEP/352
- Conditions
- Anesthesia, Regional, Anesthesia and Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, prospective, randomized controlled trial compared rebound pain (RP) occurrence following popliteal sciatic nerve block versus ankle block in patients undergoing elective forefoot bone surgery.
Patients were randomized to receive one of the two ultrasound-guided, single-injection peripheral nerve block techniques, combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion.
The primary objective was to compare RP incidence between the two block techniques. Secondary exploratory objectives included assessing postoperative pain trajectories and perioperative changes in skin temperature and tissue oxygen saturation as indirect indicators of local vasomotor and/or inflammatory responses.
Rebound pain was operationally defined as initially mild postoperative pain (NRS <4 at post-anesthesia care unit discharge), followed by severe pain (NRS ≥7) in the context of block resolution, typically described within 12-24 hours after block resolution. The exact interval between sensory recovery and severe pain onset was not systematically recorded.
Detailed description
This prospective, randomized, single-center controlled trial compared popliteal sciatic nerve block with ankle block in patients undergoing elective forefoot bone surgery. Participants were randomly allocated in a 1:1 ratio to either regional anesthetic technique, combined with standardized general anesthesia.
All peripheral nerve blocks were performed under ultrasound guidance before surgery using ropivacaine 0.5% with adrenaline (1:400,000) and clonidine (75 µg). Ankle blocks targeted the nerves supplying the surgical territory, while popliteal sciatic nerve blocks were supplemented by saphenous nerve blockade when required.
Before recruitment, the general anesthesia protocol was modified from the initially registered regimen involving sevoflurane maintenance to propofol target-controlled infusion for both induction and maintenance. This modification aimed to standardize anesthetic management and limit potential confounding effects on postoperative pain assessment. Sufentanil was reserved for intraoperative rescue analgesia but was not required. No intravenous ketamine, dexmedetomidine, or dexamethasone was administered.
Perioperative physiological assessments included infrared skin temperature measurements and tissue oxygen saturation monitoring using INVOS near-infrared spectroscopy on the operated and contralateral limbs. The originally planned Periflux measurements were discontinued before recruitment because the local heating required by this technique could interfere with skin temperature assessment. Preoperative hs-CRP and neutrophil-to-lymphocyte ratio measurements were performed, but the originally planned postoperative biomarker assessments were not conducted.
Postoperative analgesia was standardized using paracetamol and ibuprofen, with tramadol available as rescue medication. Patients remained hospitalized for approximately 24-48 hours, allowing clinical monitoring during sensory block regression and recovery. Follow-up assessments were conducted during hospitalization and by telephone on postoperative days 4 and 30 and at 3 months.
The study primarily compared rebound pain occurrence between the two regional anesthetic techniques. However, the exact onset of severe pain was not systematically timestamped, preventing reliable reconstruction of the originally registered 24-hour endpoint. The operational assessment and corresponding sensitivity analysis are specified in the Outcome Measures section.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Popliteal sciatic nerve block | Other | Other: Forefoot bone surgeryAn ultrasound-guided popliteal sciatic nerve block was performed using ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The popliteal block generally required 20-30 mL of local anesthetic solution. An additional ultrasound-guided saphenous nerve block was performed when indicated by the surgical territory, with total administered volumes reaching up to 40 mL. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg. The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI). |
| Ankle block | Other | Other: Forefoot bone surgeryAn ultrasound-guided ankle block was performed using 15-20 mL of ropivacaine 0.5% combined with adrenaline (1:400,000) and clonidine (75 μg). The block targeted the saphenous, superficial peroneal, deep peroneal, and tibial nerves. The maximum permitted ropivacaine dose was 4 mg/kg, not exceeding 300 mg. The regional anesthesia technique was combined with standardized general anesthesia induced and maintained using propofol target-controlled infusion (TCI). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any surgery of the bones of the lower limbs performed as part of a PNB associated with general anaesthesia after lower limb bone surgery
- Patient aged between 18 and 75 years old.
Key exclusion criteria (6 listed)
- refusal to participate
- contraindication to the use of local anesthetics
- contraindication to the use of general anesthesia
- contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
- cognitive disorders
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 |
|---|---|---|
| Forefoot bone surgeryElective forefoot bone surgery under popliteal sciatic nerve | Other | Popliteal sciatic nerve block |
| Forefoot bone surgeryElective forefoot bone surgery under an ankle block | Other | Ankle block |
Primary outcome
Incidence of rebound pain following peripheral nerve block resolution
Time frame: During postoperative hospitalization (approximately 24-48 hours), including the period of sensory block resolution.
Rebound pain was assessed as severe postoperative pain (NRS ≥7) following initially mild pain (NRS <4) at post-anesthesia care unit discharge, in the context of peripheral nerve block resolution. Incidence was compared between popliteal sciatic nerve block and ankle block groups. A sensitivity analysis used the stricter NRS >7 threshold. The exact onset of severe pain was not systematically timestamped; therefore, the originally registered 24-hour endpoint could not be reliably reconstructed.
11 secondary outcomes
Perioperative changes in skin temperature
Time frame: Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Perioperative changes in tissue oxygen saturation
Time frame: Perioperative period (before and after peripheral nerve block, at emergence from general anesthesia) and postoperative day 1 (POD1).
Preoperative Pain Catastrophizing Scale (PCS) score
Time frame: Preoperatively, before peripheral nerve block administration.
Preoperative Amsterdam Preoperative Anxiety and Information Scale (APAIS) score
Time frame: Preoperatively, before peripheral nerve block administration.
Preoperative Central Sensitization Inventory (CSI-9) score
Time frame: Preoperatively, before peripheral nerve block administration.
Preoperative DN4 questionnaire score
Time frame: Preoperatively, before peripheral nerve block administration.
Postoperative DN2 score at day 4
Time frame: Postoperative day 4.
Postoperative DN2 score at day 30
Time frame: Postoperative day 30.
Postoperative DN2 score at 3 months
Time frame: 3 months after surgery.
Preoperative high-sensitivity C-reactive protein (hs-CRP) level
Time frame: Preoperatively, before surgery.
Preoperative neutrophil-to-lymphocyte ratio (NLR)
Time frame: Preoperatively, before surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 33390261Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
- Background: PubMed 35513729Streb T, Schneider A, Wiesmann T, Riecke J, Schubert AK, Dinges HC, Volberg C. [Rebound pain-From definition to treatment]. Anaesthesiologie. 2022 Aug;71(8):638-645. doi: 10.1007/s00101-022-01120-z. Epub 2022 May 5. German.
- Background: PubMed 33551124Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available.
- Background: PubMed 35219449Touil N, Pavlopoulou A, Barbier O, Libouton X, Lavand'homme P. Evaluation of intraoperative ketamine on the prevention of severe rebound pain upon cessation of peripheral nerve block: a prospective randomised, double-blind, placebo-controlled study. Br J Anaesth. 2022 Apr;128(4):734-741. doi: 10.1016/j.bja.2021.11.043. Epub 2022 Feb 23.
- Background: PubMed 30411313Sort R, Brorson S, Gogenur I, Nielsen JK, Moller AM. Rebound pain following peripheral nerve block anaesthesia in acute ankle fracture surgery: An exploratory pilot study. Acta Anaesthesiol Scand. 2019 Mar;63(3):396-402. doi: 10.1111/aas.13290. Epub 2018 Nov 8.
- Background: PubMed 33546844Sort R, Brorson S, Gogenur I, Hald LL, Nielsen JK, Salling N, Hougaard S, Foss NB, Tengberg PT, Klausen TW, Moller AM. Peripheral nerve block anaesthesia and postoperative pain in acute ankle fracture surgery: the AnAnkle randomised trial. Br J Anaesth. 2021 Apr;126(4):881-888. doi: 10.1016/j.bja.2020.12.037. Epub 2021 Feb 2.
- Background: PubMed 35568510Jen TTH, Ke JXC, Wing KJ, Denomme J, McIsaac DI, Huang SC, Ree RM, Prabhakar C, Schwarz SKW, Yarnold CH. Development and internal validation of a multivariable risk prediction model for severe rebound pain after foot and ankle surgery involving single-shot popliteal sciatic nerve block. Br J Anaesth. 2022 Jul;129(1):127-135. doi: 10.1016/j.bja.2022.03.030. Epub 2022 May 12.
- Background: PubMed 22732860Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. doi: 10.1097/BOT.0b013e3182638b25.
- Background: PubMed 27547899Yamada T, Hasegawa-Moriyama M, Kurimoto T, Saito T, Kuwaki T, Kanmura Y. Peripheral Nerve Block Facilitates Acute Inflammatory Responses Induced by Surgical Incision in Mice. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):593-600. doi: 10.1097/AAP.0000000000000458.
- Background: PubMed 22092129Tighe PJ, Elliott CE, Lucas SD, Boezaart AP. Noninvasive tissue oxygen saturation determined by near-infrared spectroscopy following peripheral nerve block. Acta Anaesthesiol Scand. 2011 Nov;55(10):1239-46. doi: 10.1111/j.1399-6576.2011.02533.x. Epub 2011 Sep 26.
- Individual participant dataSharing planned: No
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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.
Nassim TOUIL, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forefoot bone surgery in people with Anesthesia, Regional and Anesthesia and Analgesia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 6 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 5 Nov 2026. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of rebound pain following peripheral nerve block resolution (time frame: During postoperative hospitalization (approximately 24-48 hours), including the period of sensory block resolution.). 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 NCT05734469, which also lists 10 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 5 Nov 2026.